510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131778Substantially Equivalent

Fusion Vascular Graft and Fusion Bioline Vascular Graft

Maquet Cardiovascular LLC, Wayne NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131778 is the FDA 510(k) clearance record for FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT, a class II device, cleared for Maquet Cardiovascular, LLC on under FDA product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter). FDA records list 14 510(k) clearances for Maquet Cardiovascular, LLC, from to . As of , FDA records show one recall naming K131778.

Clearance record

Decision date
Received
(150 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
Maquet Cardiovascular, LLC 45 Barbour Pond Dr., Wayne NJ
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