FDA Product Code
FDA Product Code DYB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1340
510(k) Clearances — 706 records · page 5 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K030944 | EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL | Edwards Lifesciences, LLC | 2003-06-20 | Traditional | PDF ↗ |
| K031583 | MODIFICATION TO IVS INTRODUCER SET, MODEL 1003 | Integrated Vascular Systems, Inc. | 2003-06-16 | Special | PDF ↗ |
| K023937 | COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM | Cook Vascular, Inc. | 2003-05-27 | Traditional | PDF ↗ |
| K031087 | EDWARDS INTRODUCER SHEATH | Edwards Lifesciences, LLC | 2003-04-24 | Traditional | PDF ↗ |
| K030905 | MEDAMICUS FLOWGUARD PEELABLE INTRODUCER | Medamicus, Inc. | 2003-04-09 | Special | PDF ↗ |
| K030723 | IVS INTRODUCER SET, MODEL 1003 | Integrated Vascular Systems, Inc. | 2003-04-03 | Traditional | PDF ↗ |
| K022170 | INNER-LOCK LOCKING INTRODUCER SHEATHS | Rex Medical | 2003-01-21 | Traditional | PDF ↗ |
| K022634 | CO-AXIAL INTRODUCER NEEDLE | Promex, Inc. | 2002-11-06 | Traditional | PDF ↗ |
| K023447 | MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) | St Jude Medical | 2002-10-31 | Special | PDF ↗ |
| K022513 | MEDCOMP VASCU-SHEATH INTRODUCER SET | Medcomp | 2002-10-25 | Traditional | PDF ↗ |
| K020964 | NEICH NM ADVANCE CATHETER SHEATH INTRODUCER | Neich Medical(Shenzhen)Company, Ltd. | 2002-10-11 | Traditional | PDF ↗ |
| K022003 | TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 | Micro Therapeutics, Inc. | 2002-09-13 | Traditional | PDF ↗ |
| K022689 | MODIFICATION TO MEDAMICUS AXIA RSN | Medamicus, Inc. | 2002-08-23 | Special | PDF ↗ |
| K021723 | SHEATH ADAPTER, MODEL SA-09847 | Arrow Intl., Inc. | 2002-08-08 | Traditional | PDF ↗ |
| K021094 | INTROCAN SAFETY IV CATHETER | B.Braun Medical, Inc. | 2002-07-03 | Traditional | PDF ↗ |
| K020834 | BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I | Becton Dickinson Infusion Therapy Systems, Inc. | 2002-06-12 | Traditional | PDF ↗ |
| K021004 | VALVED PEELABLE INTRODUCER | Medamicus, Inc. | 2002-06-06 | Traditional | PDF ↗ |
| K020563 | MEDAMICUS AXIA RSN | Medamicus, Inc. | 2002-05-21 | Traditional | PDF ↗ |
| K010128 | COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE | Cook Vascular, Inc. | 2002-04-25 | Traditional | PDF ↗ |
| K014052 | EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL | Edwards Lifesciences, LLC | 2002-03-08 | Traditional | PDF ↗ |
| K020090 | MODIFICATION TO TRANSSEPTAL INTRODUCER SET | Thomas Medical Products, Inc. | 2002-02-11 | Special | PDF ↗ |
| K003889 | ANCURE SHEATH MODEL # 40315, 40320, 40325 | Guidant Cardiac and Vascular Surgery | 2002-01-24 | Traditional | PDF ↗ |
| K012854 | RENAL GUIDING SHEATH | Terumo Medical Corp. | 2001-11-21 | Traditional | PDF ↗ |
| K012812 | CAROTID GUIDING SHEATH | Terumo Medical Corp. | 2001-11-14 | Traditional | PDF ↗ |
| K011761 | MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT | Arrow Intl., Inc. | 2001-10-31 | Traditional | PDF ↗ |
| K013202 | MODIFICATION TO BRAIDED GUIDING INTRODUCER | Thomas Medical Products, Inc. | 2001-10-23 | Special | PDF ↗ |
| K013029 | SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 | St Jude Medical | 2001-10-09 | Special | PDF ↗ |
| K010913 | VYGON SPLIT CANNULA INTRODUCER | Vygon Corp. | 2001-09-28 | Traditional | PDF ↗ |
| K012922 | ULTRAFLEX EV HEMOSTASIS INTRODUCER | St Jude Medical | 2001-09-25 | Special | PDF ↗ |
| K011790 | MICROCRUISER PLUS INTRODUCER SET | Medical Device Technologies, Inc. | 2001-09-05 | Traditional | PDF ↗ |
| K012489 | MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10 | Appriva Medical, Inc. | 2001-08-30 | Special | PDF ↗ |
| K004025 | SPLITTABLE SHEATH INTRODUCER KIT | Thomas Medical Products, Inc. | 2001-07-19 | Traditional | PDF ↗ |
| K011085 | GUIDEWIRE INTRODUCER SAFETY NEEDLE | Medamicus, Inc. | 2001-07-09 | Traditional | PDF ↗ |
| K004026 | BRAIDED GUIDING INTRODUCER | Thomas Medical Products, Inc. | 2001-07-09 | Traditional | PDF ↗ |
| K002847 | INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX | Maxxim Medical | 2001-05-31 | Abbreviated | PDF ↗ |
| K002973 | EMBOL-X INTRODUCER, MODEL CF00200 | Embol-X, Inc. | 2001-04-26 | Traditional | PDF ↗ |
| K003731 | SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE | Thomas Medical Products, Inc. | 2001-04-10 | Traditional | PDF ↗ |
| K002507 | TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT | Arrow Intl., Inc. | 2001-03-21 | Traditional | PDF ↗ |
| K002054 | X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1 | Appriva Medical, Inc. | 2001-02-16 | Traditional | PDF ↗ |
| K001985 | INTRODEUCE DOUBLE LUMEN INTRODUCER | Cook, Inc. | 2001-01-25 | Traditional | PDF ↗ |
| K003729 | ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F), | St Jude Medical | 2001-01-03 | Special | PDF ↗ |
| K000004 | ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 | Daig Corp. | 2000-11-29 | Traditional | PDF ↗ |
| K003424 | PINNACLE R/O II OR RADIFOCUS INTRODUCER II | Terumo Medical Corp. | 2000-11-21 | Special | PDF ↗ |
| K002676 | ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER | Guidant Cardiac and Vascular Surgery | 2000-10-30 | Traditional | PDF ↗ |
| K001926 | VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES | Thoratec Laboratories Corp. | 2000-09-22 | Traditional | PDF ↗ |
| K002365 | DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET | Datascope Corp. | 2000-08-25 | Special | PDF ↗ |
| K001135 | 6F & 7F INTRODUCING CATHETERS (MODIFICATION) | Cordis Corp. | 2000-07-03 | Special | PDF ↗ |
| K000313 | TEARAWAY INTRODUCER SHEATH | Xentek Medical, Inc. | 2000-06-16 | Traditional | PDF ↗ |
| K001367 | FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX | St. Jude Medical, Inc. | 2000-05-31 | Special | PDF ↗ |
| K992668 | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS) | Innerdyne, Inc. | 2000-05-26 | Traditional | PDF ↗ |
| K001346 | ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX | St. Jude Medical, Inc. | 2000-05-24 | Special | PDF ↗ |
| K994334 | ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX | Daig Corp. | 2000-05-15 | Special | PDF ↗ |
| K001139 | PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M | Biosense Webster, Inc. | 2000-05-10 | Special | PDF ↗ |
| K000824 | PERCUTANEOUS INTRODUCER, MODEL 10383-XXX | Medamicus, Inc. | 2000-04-13 | Special | PDF ↗ |
| K993191 | TFX MEDICAL INTRODUCER ASSEMBLY | Tfx Medical, Inc. | 2000-03-24 | Traditional | PDF ↗ |
| K990975 | IN-LINE HEMOSTASIS VALVE | Merit Medical Systems, Inc. | 2000-03-15 | Traditional | PDF ↗ |
| K991647 | TFX MEDICAL INTRODUCER KIT | Tfx Medical Group | 2000-01-04 | Traditional | PDF ↗ |
| K994252 | INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE | Boston Scientific Corp | 2000-01-04 | Special | PDF ↗ |
| K992309 | INTRODUCER SHEATH, VESSEL DILATOR | Boston Scientific Corp | 1999-10-07 | Traditional | PDF ↗ |
| K983940 | EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR | Adam Spence Corp. | 1999-07-15 | Traditional | PDF ↗ |
| K990705 | MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET | Medamicus, Inc. | 1999-06-28 | Traditional | PDF ↗ |
| K983039 | EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF | Schneider/Namic | 1999-05-07 | Traditional | PDF ↗ |
| K984062 | SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229 | Diag Corp. | 1999-03-24 | Traditional | PDF ↗ |
| K984260 | PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR) | Terumo Medical Corp. | 1999-01-26 | Special | PDF ↗ |
| K984500 | CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM | Cordis Corp. | 1998-12-23 | Special | PDF ↗ |
| K982797 | BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB | Luther Medical Products, Inc. | 1998-11-30 | Traditional | PDF ↗ |
| K981909 | BAXTER HEMOSTASIS VALVE INTRODUCERS | Baxter Edwards | 1998-11-24 | Traditional | PDF ↗ |
| K983023 | MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM | Cordis Corp. | 1998-10-01 | Special | PDF ↗ |
| K982187 | FAST-CATH INTRA-CARDIAC INTRODUCER | Daig Corp. | 1998-09-16 | Traditional | PDF ↗ |
| K980578 | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) | Innerdyne, Inc. | 1998-09-11 | Traditional | PDF ↗ |
| K982740 | CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S | Cordis Webster, Inc. | 1998-08-28 | Special | PDF ↗ |
| K981782 | LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM | Arrow Intl., Inc. | 1998-08-12 | Traditional | PDF ↗ |
| K980504 | EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET | Schneider/Namic | 1998-08-07 | Traditional | PDF ↗ |
| K973840 | FAST-CATH (TM) INTRA-CARDIAC INTRODUCER | Daig Corp. | 1998-05-21 | Traditional | PDF ↗ |
| K970229 | ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET | Arrow Intl., Inc. | 1998-02-13 | Traditional | PDF ↗ |
| K974448 | CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM | Cordis Corp. | 1998-02-06 | Traditional | PDF ↗ |
| K973007 | DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER | Datascope Corp. | 1997-11-06 | Traditional | PDF ↗ |
| K970264 | CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM | Cordis Webster, Inc. | 1997-10-28 | Traditional | PDF ↗ |
| K972684 | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM | Innerdyne, Inc. | 1997-10-10 | Traditional | PDF ↗ |
| K972570 | HEARTPORT INTRODUCER SHEATH | Heartport, Inc. | 1997-10-01 | Traditional | PDF ↗ |
| K965167 | PERCUTANEOUS VENOUS INTRODUCER 10264 | Medamicus, Inc. | 1997-07-25 | Traditional | PDF ↗ |
| K971608 | CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM | Cordis Corp. | 1997-07-21 | Traditional | PDF ↗ |
| K964518 | FAST-CATH TRANSSEPTAL CATHETER INTRODUCER | Daig Corp. | 1997-05-14 | Traditional | PDF ↗ |
| K964814 | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER | Bipore, Inc. | 1997-05-07 | Traditional | PDF ↗ |
| K964034 | TRANSJUGULAR ACCESS SET | AngioDynamics, Inc. | 1997-05-06 | Traditional | PDF ↗ |
| K963886 | EVS | Applied Medical Resources | 1997-04-24 | Traditional | PDF ↗ |
| K970201 | GSI CANNULA WITH INTRODUCER | General Surgical Innovations | 1997-04-21 | Traditional | PDF ↗ |
| K962978 | CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM | Johnson & Johnson Medical, Inc. | 1997-01-07 | Traditional | PDF ↗ |
| K961780 | HEMODIALYSIS INTRODUCER SET | Thomas Medical Products, Inc. | 1996-12-24 | Traditional | PDF ↗ |
| K962180 | CATH SEAL | Universal Medical Instrument Corp. | 1996-11-07 | Traditional | PDF ↗ |
| K962746 | CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT | Cordis Corp. | 1996-10-11 | Traditional | PDF ↗ |
| K961745 | BRAUN PERCUTANEOUS INTRODUCER SET | B.Braun Medical, Inc. | 1996-09-17 | Traditional | PDF ↗ |
| K961466 | PERCUTANEOUS INTRODUCER SET | Thomas Medical Products, Inc. | 1996-09-12 | Traditional | PDF ↗ |
| K960445 | INPUT TUOHY-BORST LOCKING DEVICE | C.R. Bard, Inc. | 1996-08-12 | Traditional | PDF ↗ |
| K960625 | SPREADABLE SHEATH INTRODUCER SET | Neostar Medical Technologies, Inc. | 1996-08-08 | Traditional | PDF ↗ |
| K960200 | INTROSTAT LEAD INTRODUCER | Msi, Inc. | 1996-07-02 | Traditional | PDF ↗ |
| K961513 | PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET | Ep Medsystems | 1996-05-13 | Traditional | PDF ↗ |
| K961135 | INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F) | C.R. Bard, Inc. | 1996-04-30 | Traditional | PDF ↗ |
| K960406 | BRAUN HEMOSTASIS INTRODUCERS | B.Braun Medical, Inc. | 1996-04-12 | Traditional | PDF ↗ |
| K954906 | FIRST PICC INTRODUCER CATHETER | Becton Dickinson Vascular Access, Inc. | 1996-04-08 | Traditional | PDF ↗ |
Product code DYB · Class II · Cardiovascular. Data: openFDA.