Product code DWS— Cardiovascular
ROTARY VASCULAR KNIFE
- Classification name
- Instruments, Surgical, Cardiovascular
- Device class
- Class 1
- Regulation
- 21 CFR 870.4500
- Advisory panel
- Cardiovascular
- Total cleared
- 71
- First cleared
- Most recent
Market context for product code DWS
FDA has cleared devices under product code DWS between 1976 and 2002, filed by 52 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2002
- 1997
- 1996
- 1994
- 1990
- 1989
- 1988
- 1986
- 1985
- 1984
- 1983
- 1982
- 1981
- 1980
- 1979
Top applicants under product code DWS
Recent clearances under product code DWS
- K022238 — MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
- K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)
- K962771 — BURKE CONGENITAL THORACOSCOPY INSTRUMENTS
- K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY
- K960139 — G.E. STERILE ANGIOGRAPHIC TRAY
- K960144 — G.E. STERILE CT BIOPSY TRAY
- K960143 — G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY
- K934727 — REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER
- K900379 — HYCULT DIAMOND CORONARY BYPASS KNIFE
- K896307 — INSULATION PAD
- K894738 — MODEL 6888 LEAD TUNNELER
- K892804 — NEWCHILL(TM) CARDIAC INSULATOR
- K893436 — MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT
- K891000 — MODIFIED EXTERNAL PAD
- K890432 — DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM)
- K890707 — PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL
- K882981 — PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP
- K883135 — PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE)
- K882367 — METATECH MICROCLIP APPLICATOR
- K881796 — UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE
- K882479 — 26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP
- K881717 — PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE)
- K881392 — CARDICAD(TM)
- K875016 — BIOSURGE MODEL ILVC-1
- K874960 — CARDIOVASCULAR SURGICAL INSTRUMENTS
- K864461 — MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY
- K861745 — VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET
- K851825 — SCANLAN TUNNELER, SHEATH & TIP
- K851832 — NAMAN POTTS COURNAND NEEDLE
- K851833 — MANAN SELDINGER NEEDLE
- K851834 — MANAN GWI GUIDE WIRE INTRODUCER
- K851152 — MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR
- K851140 — TELEFLEX MEDICAL INTRODUCER NEEDLE
- K850394 — LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR
- K844584 — GORE-TEX TUNNELER
- K841468 — PMA ANGIOGRAPHY TRAY
- K840305 — CATEGORY 1 CIRCULATORY SYSTEM DEVICE
- K833547 — ROTARY VASCULAR KNIFE
- K831455 — LEATHER VALVE CUTTER
- K823764 — SCANLAN SINGLE-USE AORTA PUNCH
- K830471 — KELLY-WICK TANNELER
- K823094 — CARDIAC ELEVATOR
- K822829 — ROTARY VASCULAR KNIFE
- K821569 — LEATHER VALVULOTOME
- K820258 — DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH
- K813284 — VENOUS CANNULA TRAY
- K810890 — NEOLOOPS
- K802079 — DEKNATEL GOOSEN VASCULAR PUNCH BLADES
- K801393 — AIR ASPIRATOR NEEDLE
- K800122 — HANCOCK AORTIC PUNCH
- K792576 — CASTROVIEJO VASCULAR SCISSORS
- K792088 — AORTIC OCCLUDER #000390
- K791710 — CARDIOVASCULAR INSTRUMENTS-VARIOUS
- K791370 — SILICONE SURGICAL VESSEL LOOPS
- K790124 — GRAFT TUNNELER
- K781336 — SURGITEK DISPOSABLE FLO-RESTER
- K780567 — AORTIC PUMP
- K780247 — IMPCO DISPOSABLE AORTIC PUNCH
- K771625 — LEININGEO AORTIC PUNCH #310-395 & 397
- K771026 — HUANG VEIN HOLDER, #21-8011
- K761328 — ANASTOMASIS OCCLUDER
- K761161 — 67-8006 DARLING-LINTON AORTIC TOURN.
- K760791 — COOLEY ANGLED SCISSOR - 1MM PROBE POINT
- K760792 — SCISSOR - 1.5MM PROBE POINT, ANGLED
- K760645 — CAROTID ARTERY ARTERIOTOMY CLOSURE CLAMP
- K760646 — CAROTID ARTERY CLAMP W/PILLING LMM
- K760648 — TIBIAL ARTERY CLAMP W/ATRAUGRIP JAWS
- K760624 — SMALL VESSEL CANNULA
- K760351 — CATHETER, ARGYLE THORACIC
- K760087 — TAPE, VASCULAR, 1/4 DACRON
- K760136 — CATHETER, THORACIC DRAIN
Data sourced from openFDA. This site is unofficial and independent of the FDA.