510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K063631Substantially Equivalent

Polyperf / Polyperf Safe

Laboratoires Perouse, Ivry Le Temple, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063631 is the FDA 510(k) clearance record for POLYPERF / POLYPERF SAFE, a class II device, cleared for Laboratoires Perouse on under FDA product code FPA (Set, Administration, Intravascular). FDA records list one 510(k) clearance for Laboratoires Perouse. As of , FDA records show no recalls naming K063631.

Clearance record

Decision date
Received
(303 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Laboratoires Perouse Rte. Du Manoir, Ivry Le Temple, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FPA

Trailing 12 months
5 clearances under product code FPA in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260