Home / 510(k) Clearances / K992537

510(k) K992537

PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED by Bio-Vascular, Inc. — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2000
Date Received
July 29, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Other clearances by Bio-Vascular, Inc.

  • K002233 — BVI SLING (October 13, 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)
  • K971048 — PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT (May 9, 1997)

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  • K223052 — Peri-Guard and Supple Peri-Guard (April 7, 2023)
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  • K213163 — VersaWrap (October 29, 2021)
  • K213125 — PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECU (October 27, 2021)
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