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 4 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K101399 | COAXIAL INTRODUCER SET | Martech Medical Products | 2010-06-17 | Traditional | PDF ↗ |
| K092097 | A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH | A.B. Korkor Medical, Inc. | 2010-05-06 | Traditional | PDF ↗ |
| K100615 | ARSTASIS ACCESS SYSTEM | Arstasis, Inc. | 2010-03-30 | Special | PDF ↗ |
| K093791 | GORE DRYSEAL SHEATH | W. L. Gore & Associates, Inc. | 2010-03-22 | Traditional | PDF ↗ |
| K093232 | OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER | Great Batch Medical | 2010-03-15 | Traditional | PDF ↗ |
| K091006 | ITG VASCULAR ACCESS SYSTEM, MODEL 300 | Arstasis, Inc. | 2010-02-25 | Traditional | PDF ↗ |
| K093026 | FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER | Footprint Medical | 2010-02-24 | Traditional | PDF ↗ |
| K093022 | THE PICC WAND PEELABLE SAFETY INTRODUCER | Access Scientific, Inc. | 2010-01-20 | Traditional | PDF ↗ |
| K091954 | MICRO-STICK SET | Medcomp | 2010-01-08 | Traditional | PDF ↗ |
| K091367 | GDS-DCS | Guided Delivery Systems | 2009-11-05 | Traditional | PDF ↗ |
| K093130 | ENGAGE TR INTRODUCER | St Jude Medical | 2009-11-04 | Special | PDF ↗ |
| K093023 | PTFE PEELABLE INTRODUCER | Great Batch Medical | 2009-10-29 | Special | PDF ↗ |
| K092575 | ENGAGE/ENGAGE TR | St Jude Medical | 2009-10-08 | Traditional | PDF ↗ |
| K092014 | SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER | Onset Medical Corporation | 2009-10-08 | Traditional | PDF ↗ |
| K090394 | VALVED TEARWAY INTRODUCER | Medcomp | 2009-09-01 | Traditional | PDF ↗ |
| K090867 | AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002 | Ep Dynamics, Inc. | 2009-07-30 | Traditional | PDF ↗ |
| K090114 | MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S | Oscor, Inc. | 2009-06-04 | Special | PDF ↗ |
| K091329 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | Terumo Medical Corp. | 2009-05-29 | Special | PDF ↗ |
| K091137 | ULTIMUM/ENGAGE/ENGAGE TR | St Jude Medical | 2009-04-22 | Traditional | PDF ↗ |
| K090999 | BIOCARDIA MORPH SHEATH GUIDE | Biocardia, Inc. | 2009-04-15 | Traditional | PDF ↗ |
| K090372 | THE WAND MICROACCESS SAFETY INTRODUCER | Access Scientific, Inc. | 2009-03-30 | Traditional | PDF ↗ |
| K083855 | MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59 | Acumen Medical, Inc. | 2009-02-17 | Special | PDF ↗ |
| K083269 | CROSSOVER | Thomas Medical Products, Inc. | 2009-02-03 | Traditional | PDF ↗ |
| K083402 | AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323 | St Jude Medical | 2008-12-15 | Special | PDF ↗ |
| K081645 | AGILIS NXT STEERABLE INTRODUCER, MODEL G408324 | St Jude Medical | 2008-12-09 | Special | PDF ↗ |
| K082580 | SPECTRA GUIDEWIRE INTRODUCER NEEDLE | Spectra Medical Devices, Inc. | 2008-12-08 | Traditional | PDF ↗ |
| K081697 | THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 | Access Scientific, Inc. | 2008-12-04 | Traditional | PDF ↗ |
| K083083 | AGILIS NXT STEERABLE INTRODUCER | St Jude Medical | 2008-11-06 | Traditional | PDF ↗ |
| K082847 | PINNACLE ROII INTRODUCER SHEATH | Terumo Medical Corp. | 2008-10-29 | Special | PDF ↗ |
| K082063 | PRELUDE SHORT SHEATH INTRODUCER | Merit Medical Systems, Inc. | 2008-10-15 | Traditional | PDF ↗ |
| K082644 | GLIDESHEATH | Terumo Medical Corp. | 2008-09-18 | Traditional | PDF ↗ |
| K081394 | PTFE INTERLOCK PEELABLE INTRODUCERS | Enpath Medical, Inc. | 2008-09-15 | Special | PDF ↗ |
| K082356 | GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE | W. L. Gore & Associates, Inc. | 2008-08-28 | Special | PDF ↗ |
| K081045 | DESTINATION RENAL GUIDING SHEATH | Terumo Medical Corp. | 2008-05-28 | Special | PDF ↗ |
| K081046 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | Terumo Medical Corp. | 2008-05-21 | Special | PDF ↗ |
| K081341 | REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) | Thomas Medical Products, Inc. | 2008-05-14 | Traditional | PDF ↗ |
| K073434 | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER | Bipore, Inc. | 2008-04-01 | Special | PDF ↗ |
| K080500 | MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 | Acumen Medical, Inc. | 2008-03-13 | Special | PDF ↗ |
| K072719 | CONVOY ADVANCED DELIVERY SHEATH | Boston Scientific Corp | 2008-03-07 | Traditional | PDF ↗ |
| K080415 | DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | Terumo Medical Corp. | 2008-03-07 | Special | PDF ↗ |
| K073100 | INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S | Oscor, Inc. | 2007-11-30 | Special | PDF ↗ |
| K072248 | VIAPEEL PEELABLE INTRODUCER | Enpath Medical, Inc. | 2007-11-09 | Special | PDF ↗ |
| K072130 | PTFE PEEL AWAY MICROINTRODUCER | Intromed | 2007-10-31 | Traditional | PDF ↗ |
| K070865 | EXPANDING VASCULAR SHEATH | Applied Medical | 2007-10-23 | Traditional | PDF ↗ |
| K070816 | PERIPHERAL GUIDING SHEATH | Micrus Design Technology, Inc. | 2007-09-19 | Traditional | PDF ↗ |
| K063658 | INTRAVASCULAR INTRODUCER SYSTEM | Applied Medical Resources Corp. | 2007-09-12 | Special | PDF ↗ |
| K071574 | STIFFER COAXIAL MICRO-INTRODUCER KIT | Enpath Medical, Inc. | 2007-07-05 | Special | PDF ↗ |
| K070417 | ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 | St Jude Medical | 2007-06-05 | Traditional | PDF ↗ |
| K070396 | MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45 | Acumen Medical, Inc. | 2007-05-22 | Special | PDF ↗ |
| K070166 | STRADA CAROTID GUIDING SHEATH | St Jude Medical | 2007-04-06 | Traditional | PDF ↗ |
| K062852 | BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 | Onset Medical Corporation | 2007-02-23 | Traditional | PDF ↗ |
| K070197 | ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY | Acumen Medical, Inc. | 2007-02-23 | Special | PDF ↗ |
| K063182 | ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX | Enpath Medical, Inc. | 2006-12-21 | Traditional | PDF ↗ |
| K062446 | MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH | Terumo Medical Corp. | 2006-10-23 | Special | PDF ↗ |
| K062858 | MODIFICATION TO GLIDESHEATH | Terumo Medical Corp. | 2006-10-20 | Special | PDF ↗ |
| K062145 | MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 | Acumen Medical, Inc. | 2006-08-23 | Special | PDF ↗ |
| K061015 | FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER | St Jude Medical | 2006-08-03 | Special | PDF ↗ |
| K053092 | MEDCOMP VASCU-SHEATH II | Medcomp | 2006-08-01 | Traditional | PDF ↗ |
| K061363 | AGILIS NXT STEERABLE INTRODUCER | St Jude Medical | 2006-07-12 | Special | PDF ↗ |
| K060902 | STARCLOSE INTRODUCER SET MODEL- 1002 | Abbott Vascular, Inc. | 2006-07-07 | Special | PDF ↗ |
| K060666 | CAROTID ACCESS KIT | Terumo Medical Corp. | 2006-06-29 | Traditional | PDF ↗ |
| K053400 | ACUMEN SINGLE-LUMEN DELIVERY SHEATH | Acumen Medical, Inc. | 2006-06-19 | Traditional | PDF ↗ |
| K060519 | INTRODUCER ASSEMBLY WITH ROTATOR LOCK | Teleflex Medical | 2006-05-05 | Special | PDF ↗ |
| K060190 | SUPER SHEATH XL INTRODUCER SHEATH | Togo Medikit Co., Ltd. | 2006-04-04 | Special | PDF ↗ |
| K051513 | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER | Bipore, Inc. | 2005-12-07 | Abbreviated | PDF ↗ |
| K052644 | SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER | St Jude Medical | 2005-12-05 | Special | PDF ↗ |
| K051248 | VYGON MICRO-ACCESS SAFETY INTRODUCER KIT | Vygon Corp. | 2005-10-27 | Traditional | PDF ↗ |
| K052185 | DESTINATION CAROTID GUIDING SHEATH | Terumo Medical Corp. | 2005-09-06 | Special | PDF ↗ |
| K051515 | MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 | Acumen Medical, Inc. | 2005-09-01 | Special | PDF ↗ |
| K051601 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | Terumo Medical Corp. | 2005-08-04 | Traditional | PDF ↗ |
| K051468 | INNER-LOCK INTRODUCER SHEATH | Rex Medical | 2005-08-04 | Special | PDF ↗ |
| K051096 | APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582 | St. Jude Medical, Daig Division, Inc. | 2005-05-17 | Special | PDF ↗ |
| K043084 | PREMERE DELIVERY SHEATH, MODEL PDS | Velocimed, Inc. | 2005-05-02 | Traditional | PDF ↗ |
| K050023 | SECURELOC; ADVANCINTRODUCER | Specialized Health Products, Inc. | 2005-02-18 | Traditional | PDF ↗ |
| K042308 | SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019 | Facile Medical, Inc. | 2005-02-17 | Traditional | PDF ↗ |
| K043438 | LARGE BORE SPLITTABLE INTRODUCER KIT | Thomas Medical Products, Inc. | 2005-02-15 | Special | PDF ↗ |
| K043525 | CATHETER INTRODUCER | Galt Medical Corp. | 2005-02-09 | Special | PDF ↗ |
| K050015 | MODIFIED ACUMEN SHEATH, MODEL TTWO767 | Acumen Medical, Inc. | 2005-02-03 | Special | PDF ↗ |
| K042623 | AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304 | St. Jude Medical, Daig Division, Inc. | 2005-01-27 | Special | PDF ↗ |
| K042399 | MODIFICATION TO SHORT INTRODUCER SHEATH | Rex Medical, L.P. | 2004-12-17 | Special | PDF ↗ |
| K041708 | ENPATH SAFETY INTRODUCER | Enpath Medical Incorporated | 2004-11-30 | Traditional | PDF ↗ |
| K042376 | ACUMEN SHEATH, MODEL TTW7807 | Acumen Medical, Inc. | 2004-10-26 | Traditional | PDF ↗ |
| K041506 | INTRAVASCULAR ACCESS INTRODUCER SHEATH | Applied Medical Resources Corp. | 2004-10-15 | Special | PDF ↗ |
| K042036 | AIRGUARD VALVED INTRODUCER | C.R. Bard, Inc. | 2004-08-23 | Traditional | PDF ↗ |
| K040728 | ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT | AngioDynamics, Inc. | 2004-06-18 | Traditional | PDF ↗ |
| K040713 | MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM | Thomas Medical Products, Inc. | 2004-06-01 | Special | PDF ↗ |
| K040552 | MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 | Cryocor, Inc. | 2004-05-28 | Traditional | PDF ↗ |
| K040029 | SAFETYNET GUIDEWIRE INTRODUCER | Injectimed, Inc. | 2004-04-05 | Traditional | PDF ↗ |
| K034025 | NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC | Nmt Medical, Inc. | 2004-03-26 | Traditional | PDF ↗ |
| K040150 | MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER | Medamicus, Inc. | 2004-02-18 | Special | PDF ↗ |
| K033527 | INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER | B.Braun Medical, Inc. | 2004-02-05 | Traditional | PDF ↗ |
| K034061 | MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH | Boston Scientific Corp | 2004-01-30 | Special | PDF ↗ |
| K033681 | GLIDESHEATH | Terumo Corp. | 2003-12-11 | Special | PDF ↗ |
| K031922 | CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W | Merit Medical Systems, Inc. | 2003-10-01 | Special | PDF ↗ |
| K032569 | SHORT INTRODUCER SHEATH | Rex Medical | 2003-09-16 | Special | PDF ↗ |
| K030734 | PATHWAY ACCESS SHEATH CATHETER | Vertelink Corporation | 2003-09-10 | Traditional | PDF ↗ |
| K032404 | SELDINGER SAFETY NEEDLE INTRODUCER | Hdc Corp. | 2003-09-10 | Special | PDF ↗ |
| K032073 | GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE | W. L. Gore & Associates, Inc. | 2003-08-13 | Traditional | PDF ↗ |
| K031906 | APEEL CS CATHETER DELIVERY SYSTEM | St Jude Medical | 2003-07-18 | Special | PDF ↗ |
| K030135 | SAFETY INTRODUCER NEEDLE | B.Braun Medical, Inc. | 2003-07-15 | Traditional | PDF ↗ |
Product code DYB · Class II · Cardiovascular. Data: openFDA.