510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990503Substantially Equivalent

Sulzer Vascutek Gelsoft Vascular Prosthesis

Sulzermedica, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990503 is the FDA 510(k) clearance record for SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS, a class II device, cleared for Sulzermedica on under FDA product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter). FDA records list 5 510(k) clearances for Sulzermedica, from to . As of , FDA records show one recall naming K990503.

Clearance record

Decision date
Received
(295 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
Sulzermedica 1300 E. Anderson Ln., Austin TX
510(k) summary
Summary
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