510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K101354Substantially Equivalent

Fetch 2 Aspiration Catheter Model 109400-001

Medrad Interventional/Possis, Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101354 is the FDA 510(k) clearance record for FETCH 2 ASPIRATION CATHETER MODEL 109400-001, a class II device, cleared for Medrad Interventional/Possis 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 2 510(k) clearances for Medrad Interventional/Possis, from to . As of , FDA records show one recall naming K101354.

Clearance record

Decision date
Received
(252 days to decision)
Product code
QEZ Aspiration Thrombectomy Catheter
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Medrad Interventional/Possis 9055 Evergreen Blvd. NW, Minneapolis MN
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