510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K831822Substantially Equivalent

Tetraflex Integrally Supported PTFE

Shiley, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831822 is the FDA 510(k) clearance record for TETRAFLEX INTEGRALLY SUPPORTED PTFE, a class II device, cleared for Shiley, Inc. on under FDA product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter). FDA records list 174 510(k) clearances for Shiley, Inc., from to . As of , FDA records show no recalls naming K831822.

Clearance record

Decision date
Received
(497 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
Shiley, Inc. 4221 Richmond Rd., NW, Walker MI
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