510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091703Substantially Equivalent

Hd Guide Catheter, Model 90019, 90022, 90023, 90120, 90121, 90130, 90131

Concentric Medical, Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091703 is the FDA 510(k) clearance record for HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131, a class II device, cleared for Concentric Medical, Inc. on under FDA product code QEZ (Aspiration Thrombectomy Catheter). FDA's definition for product code QEZ reads: "To remove thrombus from the peripheral and/or coronary vasculature through aspiration". FDA records list 46 510(k) clearances for Concentric Medical, Inc., from to . As of , FDA records show no recalls naming K091703.

Clearance record

Decision date
Received
(126 days to decision)
Product code
QEZ Aspiration Thrombectomy Catheter
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Concentric Medical, Inc. 301 E. Evelyn Ave., Mountain View CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEZ

Trailing 12 months
7 clearances under product code QEZ in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QEZ, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20261
April 20261
May 20260
June 20260
July 20262
August 20260
September 20261
October 20260