510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K091987Substantially Equivalent

Anastoclip Models 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, Anastoclip

LeMaitre Vascular Inc., Bedford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K091987 is the FDA 510(k) clearance record for ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP, a class II device, cleared for LeMaitre Vascular, Inc. on under FDA product code FZP (Clip, Implantable). FDA records list 35 510(k) clearances for LeMaitre Vascular, Inc., from to . As of , FDA records show 2 recalls naming K091987.

Clearance record

Decision date
Received
(295 days to decision)
Product code
FZP Clip, Implantable
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
LeMaitre Vascular, Inc. 63 2nd Ave., Bedford MA
510(k) summary
Statement
Third party review
No

Clearances, product code FZP

Trailing 12 months
5 clearances under product code FZP in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FZP, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260