510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K021547Substantially Equivalent

Flowline Biopore Eptfe Vascular Graft

Jotec GmbH, Bozeman MT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021547 is the FDA 510(k) clearance record for FLOWLINE BIOPORE EPTFE VASCULAR GRAFT, a class II device, cleared for Jotec GmbH on under FDA product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter). FDA records list one 510(k) clearance for Jotec GmbH. As of , FDA records show no recalls naming K021547.

Clearance record

Decision date
Received
(259 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
Jotec GmbH 2430 N 7th Ave., Suite 4, Bozeman MT
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