510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103405Substantially Equivalent

Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4 Extraction 7F; Pronto V4 Extraction Cath

Vascular Solutions LLC, Minneapolis MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103405 is the FDA 510(k) clearance record for PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH, a class II device, cleared for Vascular Solutions, 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 115 510(k) clearances for Vascular Solutions, Inc., from to . As of , FDA records show one recall naming K103405.

Clearance record

Decision date
Received
(33 days to decision)
Product code
QEZ Aspiration Thrombectomy Catheter
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Vascular Solutions, Inc. 6464 Sycamore Ct. N., 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