510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K822134Substantially Equivalent

Shiely Duel Lumen Subclavian Cannula

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

K822134 is the FDA 510(k) clearance record for SHIELY DUEL LUMEN SUBCLAVIAN CANNULA, a class II device, cleared for Shiley, Inc. on under FDA product code LFJ (Catheter, Subclavian). FDA records list 174 510(k) clearances for Shiley, Inc., from to . As of , FDA records show no recalls naming K822134.

Clearance record

Decision date
Received
(14 days to decision)
Product code
LFJ Catheter, Subclavian
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Shiley, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LFJ

Trailing 12 months

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

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