510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K034010Substantially Equivalent

Gelsoft Plus Ers

Vascutek, Ltd., Ann Arbor MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K034010 is the FDA 510(k) clearance record for GELSOFT PLUS ERS, a class II device, cleared for Vascutek, Ltd. on under FDA product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter). FDA records list 26 510(k) clearances for Vascutek, Ltd., from to . As of , FDA records show one recall naming K034010.

Clearance record

Decision date
Received
(57 days to decision)
Product code
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Regulation
21 CFR 870.3450
Device class
Class II
Review panel
Cardiovascular
Applicant
Vascutek, Ltd. 6200 Jackson Rd., Ann Arbor MI
510(k) summary
Statement
Third party review
No

Clearances, product code DSY

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