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510(k) K905159

FLO-RESTER(R) VESSEL SIZER by Bio-Vascular, Inc. — Product Code DWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1991
Date Received
November 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, Surgical
Device Class
Class II
Regulation Number
870.4475
Review Panel
CV
Submission Type

Other clearances by Bio-Vascular, Inc.

  • K002233 — BVI SLING (October 13, 2000)
  • K992537 — PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND (February 22, 2000)
  • K983602 — CV PERI-GUARD AND VASCU-GUARD (November 12, 1998)
  • K983581 — OCU-GUARD AND OCU-GUARD SUPPLE (November 6, 1998)
  • K983162 — PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, P (October 9, 1998)
  • K981624 — FLO-THRU (August 4, 1998)
  • K982282 — DURA-GUARD - DURAL REPAIR PATCH (July 30, 1998)
  • K971726 — CV PERI-GUARD - CARDIOVASCULAR PATCH (April 10, 1998)
  • K973706 — DURA-GUARD-DURAL REPAIR PATCH (December 24, 1997)
  • K973552 — OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP (December 16, 1997)

Other clearances for product code DWP

  • K220981 — SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe (April 20, 2023)
  • K183438 — Geomed Vascular Dilators (September 3, 2019)
  • K163524 — Vessel Dilator (June 29, 2017)
  • K130896 — VASCULAR PROBE, VASCULAR PROBE ES (April 24, 2013)
  • K100518 — INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 (August 31, 2010)
  • K030788 — KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS (July 12, 2003)
  • K960312 — RDI CARDIAC INSULATION PAD (April 19, 1996)
  • K912548 — LEMAITRE-BOOKWALTER VESSEL DEVICES (September 18, 1991)
  • K911475 — LAPAROSCOPIC VESSEL ARTICULATOR (July 2, 1991)
  • K910682 — ROBICSEK PROBE/RETRACTOR (May 8, 1991)