510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K052964Substantially Equivalent

Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular Grafts, Woven Double Velour Woven

Boston Scientific Corporation, Maple Grove MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052964 is the FDA 510(k) clearance record for EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN, a class II device, cleared for Boston Scientific Corp on under FDA product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show 3 recalls naming K052964.

Clearance record

Decision date
Received
(77 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
Boston Scientific Corp Two Scimed Pl., Maple Grove MN
510(k) summary
Summary PDF
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