510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912548Substantially Equivalent

Lemaitre-Bookwalter Vessel Devices

Vascutech, Inc., Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912548 is the FDA 510(k) clearance record for LEMAITRE-BOOKWALTER VESSEL DEVICES, a class II device, cleared for Vascutech, Inc. on under FDA product code DWP (Dilator, Vessel, Surgical). FDA records list 14 510(k) clearances for Vascutech, Inc., from to . As of , FDA records show no recalls naming K912548.

Clearance record

Decision date
Received
(100 days to decision)
Product code
DWP Dilator, Vessel, Surgical
Regulation
21 CFR 870.4475
Device class
Class II
Review panel
Cardiovascular
Applicant
Vascutech, Inc. 140 Haverhill St., Andover MA
510(k) summary
Statement
Third party review
No

Clearances, product code DWP

Trailing 12 months

FDA records hold no clearances under product code DWP in the trailing twelve months.

FDA records show no clearances under product code DWP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DWP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260