510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983162Substantially Equivalent

Peri-Guard, Cv Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc

Bio-Vascular, Inc., St. Paul MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K983162 is the FDA 510(k) clearance record for PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC, a class II device, cleared for Bio-Vascular, Inc. on under FDA product code FTM (Mesh, Surgical). FDA records list 26 510(k) clearances for Bio-Vascular, Inc., from to . As of , FDA records show 2 recalls naming K983162.

Clearance record

Decision date
Received
(29 days to decision)
Product code
FTM Mesh, Surgical
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Bio-Vascular, Inc. 2575 University Ave., St. Paul MN
510(k) summary
Summary
Third party review
No

Clearances, product code FTM

Trailing 12 months
1 clearance under product code FTM in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FTM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260