FDA Product Code
FDA Product Code DXC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4450
510(k) Clearances — 205 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K023154 | VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02 | Vascular Control Systems, Inc. | 2002-12-20 | Traditional | PDF ↗ |
| K014277 | KSEA DEPLOYABLE CARDIOVASCULAR CLAMP | KARL STORZ Endoscopy-America, Inc. | 2002-12-11 | Traditional | PDF ↗ |
| K021608 | SMITHWICK CAROTID SHUNT | Implantable Devices | 2002-10-22 | Traditional | PDF ↗ |
| K022754 | S&T SINGLE USE MICRO ANASTOMOSIS CLAMP | S & T AG | 2002-10-16 | Traditional | PDF ↗ |
| K011208 | BIOVER | Biover AG | 2002-10-02 | Traditional | PDF ↗ |
| K022880 | GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 | Guidant Corp. | 2002-09-13 | Traditional | PDF ↗ |
| K010727 | FLEXLINE CLAMP | Novare Surgical Systems, Inc. | 2002-08-09 | Traditional | PDF ↗ |
| K012041 | THE HAMMER MODEL H100 | Tenacore Holdings, Inc. | 2002-03-28 | Traditional | PDF ↗ |
| K011863 | VCS-A SERIES CLAMP | Vascular Control Systems, Inc. | 2002-02-15 | Traditional | PDF ↗ |
| K010694 | INCLUDER CLAMP | Novare Surgical Systems, Inc. | 2002-02-11 | Traditional | PDF ↗ |
| K010785 | KSEA DION-GRACIA SET | KARL STORZ Endoscopy-America, Inc. | 2001-08-21 | Traditional | PDF ↗ |
| K011078 | MALLEABLE SHAFT CLAMP | Allegiance Healthcare Corp. | 2001-07-13 | Special | PDF ↗ |
| K010117 | GUIDANT AXIUS CORONARY SHUNT | Cardiothoracic Systems, Inc. | 2001-04-04 | Traditional | PDF ↗ |
| K002915 | FLEXIBLE OCCLUSION SYSTEM | Applied Medical | 2001-01-08 | Traditional | PDF ↗ |
| K002767 | COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE | Semler Technologies, Inc. | 2000-09-27 | Special | PDF ↗ |
| K992980 | ENGAGE JAW INSERTS | Novare Surgical Systems, Inc. | 2000-06-08 | Traditional | PDF ↗ |
| K000098 | SOFTLINE SPRING CLIP | Novare Surgical Systems, Inc. | 2000-04-12 | Traditional | PDF ↗ |
| K992174 | PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP | Pilling Weck Surgical | 2000-03-23 | Traditional | PDF ↗ |
| K992053 | AESCULAP VASCULAR INSTRUMENTS | Aesculap, Inc. | 2000-01-13 | Traditional | PDF ↗ |
| K992640 | SLIMLINE SURGICAL CLAMP; SLIMLINE JAW INSERTS | Minumys Surgical, Inc. | 1999-09-08 | Traditional | PDF ↗ |
| K984214 | CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER | Cordis Neurovascular, Inc. | 1999-08-10 | Traditional | PDF ↗ |
| K991589 | FLEXIBLE VASCULAR CLAMP, VERSION 2 | Allegiance Healthcare Corp. | 1999-05-18 | Special | PDF ↗ |
| K982365 | ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT | Geister Medizin Technik GmbH | 1999-04-08 | Traditional | PDF ↗ |
| K982278 | MICRINS MICRO ANASTOMOSIS CLAMP | Micrins Surgical, Inc. | 1999-03-26 | Traditional | PDF ↗ |
| K990573 | ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA | Estech, Inc. | 1999-03-11 | Traditional | PDF ↗ |
| K983471 | FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER | Radi Medical Systems AB | 1999-02-23 | Traditional | PDF ↗ |
| K980631 | EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA | Embol-X, Inc. | 1999-02-02 | Traditional | PDF ↗ |
| K982182 | FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0 | Radi Medical Systems AB | 1998-09-18 | Traditional | PDF ↗ |
| K972689 | CAOW HEMOSTASIS SYSTEM | Anlam Corp. | 1998-08-27 | Traditional | PDF ↗ |
| K981624 | FLO-THRU | Bio-Vascular, Inc. | 1998-08-04 | Traditional | PDF ↗ |
| K980128 | BALADI INVERTER WITH COAXIAL AORTIC PUNCH | Cardio Medical Solutions, Inc. | 1998-07-24 | Traditional | PDF ↗ |
| K981956 | DEGANIA SILICONE IDENTI LOOPS | Degania Silicone , Ltd. | 1998-07-09 | Traditional | PDF ↗ |
| K980087 | PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330 | Pressure Products, Inc. | 1998-07-01 | Traditional | PDF ↗ |
| K980002 | KOALA VASCULAR CLAMPS AND INSERTS | Boss Instruments, Ltd. | 1998-06-18 | Traditional | PDF ↗ |
| K974769 | COSGROVE CLAMP | Allegiance Healthcare Corp. | 1998-06-12 | Traditional | PDF ↗ |
| K980898 | FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER | Radi Medical Systems AB | 1998-04-21 | Traditional | PDF ↗ |
| K973080 | SURGICAL VASCULAR CLAMP | Walter Lorenz Surgical, Inc. | 1998-02-23 | Traditional | PDF ↗ |
| K973132 | EZ HOLD 1 LBS., EZ HOLD 2 LBS | Tz Medical, Inc. | 1998-01-12 | Traditional | PDF ↗ |
| K964663 | FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX | Rmds, Inc. | 1997-12-11 | Traditional | PDF ↗ |
| K973216 | FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T) | Rmds, Inc. | 1997-11-25 | Traditional | PDF ↗ |
| K970638 | CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT | Cardiothoracic Systems, Inc. | 1997-10-30 | Traditional | PDF ↗ |
| K970611 | ORIGIN CARDIAC STABLIZER OCCLUDER | Origin Medsystems, Inc. | 1997-08-19 | Traditional | PDF ↗ |
| K970027 | FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005 | Rmds, Inc. | 1997-08-08 | Traditional | PDF ↗ |
| K964251 | OCCLUSION CLAMP** DEVICE | United States Surgical, A Division of Tyco Healthc | 1997-05-23 | Traditional | PDF ↗ |
| K964161 | HEARTPORT ENDOAORTIC CLAMP | Heartport, Inc. | 1997-04-04 | Traditional | PDF ↗ |
| K963503 | CTS MIDCAB CORONARY SHUNT | Cardiothoracic Systems, Inc. | 1997-04-03 | Traditional | PDF ↗ |
| K963716 | MICS DEVICE SYSTEM | Percutaneous Technologies, Inc. | 1997-04-02 | Traditional | PDF ↗ |
| K964662 | FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15 | Rmds, Inc. | 1997-02-03 | Traditional | PDF ↗ |
| K964547 | DEGANIA SILICONE INDENTI LOOPS | Degania Silicone , Ltd. | 1997-01-08 | Traditional | PDF ↗ |
| K962366 | HEARTPORT CABLE BULLDOG CLAMP | Heartport, Inc. | 1996-11-07 | Traditional | PDF ↗ |
| K962668 | AMR-ACV CLAMPS | Applied Medical Resources | 1996-11-04 | Traditional | PDF ↗ |
| K955827 | DANESHVAR WOUND SUPPORT UNIT | Y. Daneshvar | 1996-10-02 | Traditional | PDF ↗ |
| K962858 | HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM | Heartport, Inc. | 1996-09-30 | Traditional | PDF ↗ |
| K962510 | HEARTPORT ENDOAORTIC CLAMP | Heartport, Inc. | 1996-09-11 | Traditional | PDF ↗ |
| K955742 | D. DEVICE II | Yousef Daneshvar | 1996-08-12 | Traditional | PDF ↗ |
| K955270 | TAPE & BANDAGE, ADHESIVE | Robert R. Stevens | 1996-08-08 | Traditional | PDF ↗ |
| K961461 | DANESHVAR'S DEVICE (MODIFICATION) | Y. Daneshvar | 1996-06-26 | Traditional | PDF ↗ |
| K961100 | MICRO ANASTOMOSIS CLAMP | R.S.P. Medical Management, Inc. | 1996-06-19 | Traditional | PDF ↗ |
| K955132 | HEARTPORT ENDOAORTIC CLAMP | Heartport, Inc. | 1996-06-07 | Traditional | PDF ↗ |
| K954669 | FEMOSTOP, FEMOSTOP PUMP | Radi Medical Systems AB | 1995-10-27 | Traditional | PDF ↗ |
| K951413 | FOGARTY-HYDRAGRIP SURGICAL CLAMPS | Baxter Healthcare Corp | 1995-08-18 | Traditional | PDF ↗ |
| K944259 | FEMOSTOP II | Radi Medical Systems AB | 1995-07-20 | Traditional | PDF ↗ |
| K943948 | PROTECTIVE SHORTS | Y. Daneshvar, M.D. | 1995-06-05 | Traditional | PDF ↗ |
| K950492 | ATRAUMAX SURGICAL CLAMP | Applied Medical Resources | 1995-05-08 | Traditional | PDF ↗ |
| K935964 | IDEAS OCCLUDER | Ideas For Medicine, Inc. | 1995-01-04 | Traditional | PDF ↗ |
| K935494 | DANESHVAR'S DEVICE | Y. Daneshvar | 1994-11-22 | Traditional | PDF ↗ |
| K942812 | FLO-RESTER DISPOSABLE VESSEL OCCLUDER | Bio-Vascular, Inc. | 1994-08-01 | Traditional | PDF ↗ |
| K925809 | COMPRESSAR UNIVERSAL (TM) SYSTEM | Instromedix, Inc. | 1993-02-22 | Traditional | PDF ↗ |
| K923085 | QUICKLAMP SYSTEM | Disco, Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K920936 | RMI EXTERNAL CORONARY ARTERY OCCLUDER | Research Medical, Inc. | 1992-12-18 | Traditional | PDF ↗ |
| K921399 | OCCLUSION BALLON CATHETER MODIFICAION | Interventional Therapeutics Corp. | 1992-09-25 | Traditional | PDF ↗ |
| K920501 | SILCLAMPS DEGANIA SILICONE | Puritas Health Care, Inc. | 1992-06-02 | Traditional | PDF ↗ |
| K915280 | FEMOSTOP | Radi Medical Systems AB | 1992-04-22 | Traditional | PDF ↗ |
| K914149 | FEMORAL ARTERY PRESSURE PAD/DISK | Disco, Inc. | 1991-12-13 | Traditional | PDF ↗ |
| K910221 | RMI VASCULAR TOURNIQUET KIT | Research Medical, Inc. | 1991-05-16 | Traditional | PDF ↗ |
| K901628 | APPLIED VASCULAR DEVICES 6MM TRACTION CLIP | Applied Vascular Devices, Inc. | 1990-07-06 | Traditional | PDF ↗ |
| K901565 | ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE | Applied Vascular Devices, Inc. | 1990-06-12 | Traditional | PDF ↗ |
| K897075 | PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER | Pioneering Technologies, Inc. | 1990-04-10 | Traditional | PDF ↗ |
| K885161 | VOSS VEIN CLAMP | Voss Medical Products | 1989-12-22 | Traditional | PDF ↗ |
| K895691 | VASCULAR CLAMP | Applied Vascular Devices, Inc. | 1989-12-13 | Traditional | PDF ↗ |
| K894670 | GENERAL SURGICAL INSTRUMENTS | Nopa Instruments | 1989-08-10 | Traditional | PDF ↗ |
| K891296 | ATRAUMAX(TM) SURGICAL CLAMPS | Applied Vascular Devices, Inc. | 1989-06-07 | Traditional | PDF ↗ |
| K883790 | SURGICAL CLAMP INSERTS | Applied Vascular Devices, Inc. | 1988-12-27 | Traditional | PDF ↗ |
| K883696 | FLO-RESTER | Bio-Vascular, Inc. | 1988-11-30 | Traditional | PDF ↗ |
| K882879 | PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER) | Pioneering Technologies, Inc. | 1988-09-12 | Traditional | PDF ↗ |
| K881448 | #557 DISPOSABLE CARDIOVASCULAR CLAMP | Alpha Industries, Inc. | 1988-06-30 | Traditional | PDF ↗ |
| K881447 | METATECH METAL MICROCLIP | Metatech Corp. | 1988-06-22 | Traditional | PDF ↗ |
| K881158 | VASCULAR CLAMP | T. Korossurgical Instruments Corp. | 1988-06-20 | Traditional | PDF ↗ |
| K875090 | AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP* | United States Surgical, A Division of Tyco Healthc | 1988-02-29 | Traditional | PDF ↗ |
| K863427 | CLAMPEASE FA | Freund Medical Products | 1986-11-20 | Traditional | PDF ↗ |
| K861924 | MICRO ANASTOMOSIS CLAMP | Pilling Co. | 1986-06-06 | Traditional | PDF ↗ |
| K851739 | DUNN VESSEL OCCLUDER-STERILE | Richard J. Turner Assoc. | 1985-09-27 | Traditional | PDF ↗ |
| K852479 | PULMONARY VEIN CLAMP | None | 1985-08-09 | Traditional | PDF ↗ |
| K831809 | FOGARTY OCCLUDER PAD | Thomas J. Fogarty, M.D. | 1984-08-27 | Traditional | PDF ↗ |
| K832554 | FOGARTY 6MM SOFTJAW CLIP | American Edwards Laboratories | 1983-09-29 | Traditional | PDF ↗ |
| K820949 | P-S BERLIN VESSEL CLAMP | Pudenz-Schulte Medical Research Corp. | 1982-04-29 | Traditional | PDF ↗ |
| K813499 | OMED DISPOSABLE BULLDOG | Omega-Med Intl., Inc. | 1981-12-29 | Traditional | PDF ↗ |
| K813062 | VASCULAR PAWS | Sil-Med Corp. | 1981-12-14 | Traditional | PDF ↗ |
| K810162 | FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06 | American Edwards Laboratories | 1981-02-04 | Traditional | PDF ↗ |
| K802244 | VESSEL RETRACTOR, #600732 | Bentley Laboratories, Inc. | 1980-10-03 | Traditional | PDF ↗ |
Product code DXC · Class II · Cardiovascular. Data: openFDA.