510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K071826Substantially Equivalent

The Rinspirator, Models Fg09770, Fg08776, Fg08777, Fg08910

Medtronic, Inc., Redwood City CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071826 is the FDA 510(k) clearance record for THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910, a class II device, cleared for Fox Hollow Technologies 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 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K071826.

Clearance record

Decision date
Received
(129 days to decision)
Product code
QEZ Aspiration Thrombectomy Catheter
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Fox Hollow Technologies 740 Bay Rd., Redwood City CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEZ

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