PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010— 510(k) K072810

Substantially Equivalent

Vascular Solutions, Inc.

FDA 510(k) clearance K072810 for PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010, Substantially Equivalent on 2007-12-19. Applicant: Vascular Solutions, Inc..

Clearance details

Applicant: Vascular Solutions, Inc.
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2007-10-01
Decision date: 2007-12-19
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.