FDA Product Code
FDA Product Code DWS — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4500
510(k) Clearances — 71 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K022238 | MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 | Medtronic Vascular | 2002-10-09 | Traditional | PDF ↗ |
| K964445 | OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) | Dlp, Inc. | 1997-01-30 | Traditional | PDF ↗ |
| K962771 | BURKE CONGENITAL THORACOSCOPY INSTRUMENTS | Pilling Weck, Inc. | 1996-11-19 | Traditional | PDF ↗ |
| K955689 | RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY | Contour Fabricators of Florida, Inc. | 1996-05-15 | Traditional | PDF ↗ |
| K960139 | G.E. STERILE ANGIOGRAPHIC TRAY | GE Medical Systems | 1996-04-19 | Traditional | PDF ↗ |
| K960144 | G.E. STERILE CT BIOPSY TRAY | GE Medical Systems | 1996-04-15 | Traditional | PDF ↗ |
| K960143 | G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY | GE Medical Systems | 1996-04-09 | Traditional | PDF ↗ |
| K934727 | REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER | Cardiac Pacemakers, Inc. | 1994-01-10 | Traditional | PDF ↗ |
| K900379 | HYCULT DIAMOND CORONARY BYPASS KNIFE | St. Jude Medical, Inc. | 1990-03-19 | Traditional | PDF ↗ |
| K896307 | INSULATION PAD | Bio-Vascular, Inc. | 1990-01-19 | Traditional | PDF ↗ |
| K894738 | MODEL 6888 LEAD TUNNELER | Cardiac Pacemakers, Inc. | 1989-09-13 | Traditional | PDF ↗ |
| K893436 | MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT | Pioneering Technologies, Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K892804 | NEWCHILL(TM) CARDIAC INSULATOR | Acacia Laboratories, Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K891000 | MODIFIED EXTERNAL PAD | Instromedix, Inc. | 1989-05-19 | Traditional | PDF ↗ |
| K890432 | DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) | Deknatel, Inc. | 1989-04-13 | Traditional | PDF ↗ |
| K890707 | PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL | Dlp, Inc. | 1989-04-10 | Traditional | PDF ↗ |
| K882981 | PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP | Pioneering Technologies, Inc. | 1988-09-27 | Traditional | PDF ↗ |
| K883135 | PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) | Pioneering Technologies, Inc. | 1988-09-26 | Traditional | PDF ↗ |
| K882367 | METATECH MICROCLIP APPLICATOR | Metatech Corp. | 1988-08-25 | Traditional | PDF ↗ |
| K881796 | UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE | Universal Medical Instrument Corp. | 1988-07-26 | Traditional | PDF ↗ |
| K882479 | 26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP | Medtronic Blood Systems, Inc. | 1988-07-18 | Traditional | PDF ↗ |
| K881717 | PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE) | Buckman Co., Inc. | 1988-07-05 | Traditional | PDF ↗ |
| K881392 | CARDICAD(TM) | Medical/Surgical Specialties, Ltd. | 1988-05-31 | Traditional | PDF ↗ |
| K875016 | BIOSURGE MODEL ILVC-1 | Biosurge, Inc. | 1988-02-29 | Traditional | PDF ↗ |
| K874960 | CARDIOVASCULAR SURGICAL INSTRUMENTS | Solway, Inc. | 1988-02-05 | Traditional | PDF ↗ |
| K864461 | MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY | Medsurg Industries, Inc. | 1986-11-24 | Traditional | PDF ↗ |
| K861745 | VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET | Keeler Instruments, Inc. | 1986-05-13 | Traditional | PDF ↗ |
| K851825 | SCANLAN TUNNELER, SHEATH & TIP | Scanlan Intl., Inc. | 1985-07-12 | Traditional | PDF ↗ |
| K851832 | NAMAN POTTS COURNAND NEEDLE | Manan Manufacturing Co., Inc. | 1985-07-11 | Traditional | PDF ↗ |
| K851833 | MANAN SELDINGER NEEDLE | Manan Manufacturing Co., Inc. | 1985-07-11 | Traditional | PDF ↗ |
| K851834 | MANAN GWI GUIDE WIRE INTRODUCER | Manan Manufacturing Co., Inc. | 1985-07-11 | Traditional | PDF ↗ |
| K851152 | MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR | Cryomedics, Inc. | 1985-06-24 | Traditional | PDF ↗ |
| K851140 | TELEFLEX MEDICAL INTRODUCER NEEDLE | Teleflexmedical, Inc. | 1985-06-19 | Traditional | PDF ↗ |
| K850394 | LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR | Vascutech, Inc. | 1985-04-24 | Traditional | PDF ↗ |
| K844584 | GORE-TEX TUNNELER | W. L. Gore & Associates, Inc. | 1985-01-24 | Traditional | PDF ↗ |
| K841468 | PMA ANGIOGRAPHY TRAY | Professional Medical Services | 1984-06-05 | Traditional | PDF ↗ |
| K840305 | CATEGORY 1 CIRCULATORY SYSTEM DEVICE | Imm Enterprises , Ltd. | 1984-04-23 | Traditional | PDF ↗ |
| K833547 | ROTARY VASCULAR KNIFE | Formedco, Inc. | 1984-01-26 | Traditional | PDF ↗ |
| K831455 | LEATHER VALVE CUTTER | American V. Mueller | 1983-07-07 | Traditional | PDF ↗ |
| K823764 | SCANLAN SINGLE-USE AORTA PUNCH | Scanlan Intl., Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K830471 | KELLY-WICK TANNELER | Intl. Medical Prosthetics Research | 1983-03-24 | Traditional | PDF ↗ |
| K823094 | CARDIAC ELEVATOR | Cardio Surgical Research, Inc. | 1982-12-15 | Traditional | PDF ↗ |
| K822829 | ROTARY VASCULAR KNIFE | Medco Products, Co., Inc. | 1982-11-17 | Traditional | PDF ↗ |
| K821569 | LEATHER VALVULOTOME | American V. Mueller | 1982-05-27 | Traditional | PDF ↗ |
| K820258 | DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH | Howmedica Corp. | 1982-03-02 | Traditional | PDF ↗ |
| K813284 | VENOUS CANNULA TRAY | Cunningham Woodland, Inc. | 1981-12-29 | Traditional | PDF ↗ |
| K810890 | NEOLOOPS | Medical Marketing Systems | 1981-08-31 | Traditional | PDF ↗ |
| K802079 | DEKNATEL GOOSEN VASCULAR PUNCH BLADES | Howmedica Corp. | 1980-09-16 | Traditional | PDF ↗ |
| K801393 | AIR ASPIRATOR NEEDLE | Texas Medical Products, Inc. | 1980-06-30 | Traditional | PDF ↗ |
| K800122 | HANCOCK AORTIC PUNCH | Hancock Laboratories, Inc. | 1980-02-01 | Traditional | PDF ↗ |
| K792576 | CASTROVIEJO VASCULAR SCISSORS | Edward Weck, Inc. | 1979-12-19 | Traditional | PDF ↗ |
| K792088 | AORTIC OCCLUDER #000390 | Edward Weck, Inc. | 1979-10-26 | Traditional | PDF ↗ |
| K791710 | CARDIOVASCULAR INSTRUMENTS-VARIOUS | Edward Weck, Inc. | 1979-09-12 | Traditional | PDF ↗ |
| K791370 | SILICONE SURGICAL VESSEL LOOPS | Conphar, Inc. | 1979-08-03 | Traditional | PDF ↗ |
| K790124 | GRAFT TUNNELER | Narco Scientific | 1979-02-08 | Traditional | PDF ↗ |
| K781336 | SURGITEK DISPOSABLE FLO-RESTER | Medical Engineering Corp. | 1978-10-10 | Traditional | PDF ↗ |
| K780567 | AORTIC PUMP | ETHICON, Inc. | 1978-04-28 | Traditional | PDF ↗ |
| K780247 | IMPCO DISPOSABLE AORTIC PUNCH | Thoratec Laboratories Corp. | 1978-02-27 | Traditional | PDF ↗ |
| K771625 | LEININGEO AORTIC PUNCH #310-395 & 397 | J. Jamner Surgical Instruments, Inc. | 1977-09-12 | Traditional | PDF ↗ |
| K771026 | HUANG VEIN HOLDER, #21-8011 | Codman & Shurtleff, Inc. | 1977-06-20 | Traditional | PDF ↗ |
| K761328 | ANASTOMASIS OCCLUDER | Medical Engineering Corp. | 1977-02-01 | Traditional | PDF ↗ |
| K761161 | 67-8006 DARLING-LINTON AORTIC TOURN. | Codman & Shurtleff, Inc. | 1976-12-06 | Traditional | PDF ↗ |
| K760792 | SCISSOR - 1.5MM PROBE POINT, ANGLED | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-11 | Traditional | PDF ↗ |
| K760791 | COOLEY ANGLED SCISSOR - 1MM PROBE POINT | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-11 | Traditional | PDF ↗ |
| K760645 | CAROTID ARTERY ARTERIOTOMY CLOSURE CLAMP | Pilling Co. | 1976-09-21 | Traditional | PDF ↗ |
| K760648 | TIBIAL ARTERY CLAMP W/ATRAUGRIP JAWS | Pilling Co. | 1976-09-21 | Traditional | PDF ↗ |
| K760646 | CAROTID ARTERY CLAMP W/PILLING LMM | Pilling Co. | 1976-09-21 | Traditional | PDF ↗ |
| K760624 | SMALL VESSEL CANNULA | Cobe Laboratories, Inc. | 1976-09-17 | Traditional | PDF ↗ |
| K760351 | CATHETER, ARGYLE THORACIC | Sherwood Medical Industries | 1976-08-23 | Traditional | PDF ↗ |
| K760136 | CATHETER, THORACIC DRAIN | Sherwood Medical Industries | 1976-07-20 | Traditional | PDF ↗ |
| K760087 | TAPE, VASCULAR, 1/4 DACRON | Meadox Medicals, Div. Boston Scientific Corp. | 1976-07-20 | Traditional | PDF ↗ |
Product code DWS · Class I · Cardiovascular. Data: openFDA.