510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963611Substantially Equivalent

Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,vascutek Gelsoft Patch,vascutek Thin Wall Carotid Patch

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

K963611 is the FDA 510(k) clearance record for VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH, a class II device, cleared for Vascutek, Ltd. on under FDA product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene). FDA records list 26 510(k) clearances for Vascutek, Ltd., from to . As of , FDA records show one recall naming K963611.

Clearance record

Decision date
Received
(72 days to decision)
Product code
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Regulation
21 CFR 870.3470
Device class
Class II
Review panel
Cardiovascular
Applicant
Vascutek, Ltd. 1300 E. Anderson Ln., Austin TX
510(k) summary
Summary
Third party review
No

Clearances, product code DXZ

Trailing 12 months

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

FDA records show no clearances under product code DXZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXZ, 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