Product code DWP— Cardiovascular
BONCHEK-SHILEY VEIN DISTENTION SYSTEM
- Classification name
- Dilator, Vessel, Surgical
- Device class
- Class 2
- Regulation
- 21 CFR 870.4475
- Advisory panel
- Cardiovascular
- Total cleared
- 20
- First cleared
- Most recent
Market context for product code DWP
FDA has cleared devices under product code DWP between 1979 and 2023, filed by 16 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2023
- 2019
- 2017
- 2013
- 2010
- 2003
- 1996
- 1991
- 1990
- 1989
- 1984
- 1983
- 1982
- 1981
- 1979
Top applicants under product code DWP
Recent clearances under product code DWP
- K220981 — SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
- K183438 — Geomed Vascular Dilators
- K163524 — Vessel Dilator
- K130896 — VASCULAR PROBE, VASCULAR PROBE ES
- K100518 — INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
- K030788 — KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS
- K960312 — RDI CARDIAC INSULATION PAD
- K912548 — LEMAITRE-BOOKWALTER VESSEL DEVICES
- K911475 — LAPAROSCOPIC VESSEL ARTICULATOR
- K910682 — ROBICSEK PROBE/RETRACTOR
- K905159 — FLO-RESTER(R) VESSEL SIZER
- K902143 — FOGARTY VESSEL CALIBRATOR
- K891786 — PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)
- K833676 — SURGICAL VESSEL DILATORS-CATHERIZA-
- K832595 — VESSEL DILATOR
- K822687 — REUSABLE FOGARTY FLEXIBLE CALIBRATOR
- K812935 — FOGARTY FLEXIBLE PROBE
- K810894 — FOGARTY FLEXIBLE CALIBRATOR
- K792134 — BONCHEK-SHILEY VEIN DISTENTION SYSTEM
- K790938 — SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO
Data sourced from openFDA. This site is unofficial and independent of the FDA.