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

Name: FDA 510(k) clearance K072810
Creator: U.S. Food and Drug Administration
Published: 2007-12-19

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.. Device class: 2.

Clearance details

Applicant: Vascular Solutions, Inc.
Product code: Code QEZ
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2007-10-01
Decision date: 2007-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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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.

Clearance details

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