PRONTO V3 EXTRACTION CATHETER, MODEL 5003— 510(k) K063371

Substantially Equivalent

Vascular Solutions, Inc.

FDA 510(k) clearance K063371 for PRONTO V3 EXTRACTION CATHETER, MODEL 5003, Substantially Equivalent on 2006-12-14. Applicant: Vascular Solutions, Inc..

Clearance details

Applicant: Vascular Solutions, Inc.
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2006-11-08
Decision date: 2006-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.