PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,— 510(k) K083784

Substantially Equivalent

Vascular Solutions, Inc.

FDA 510(k) clearance K083784 for PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,, Substantially Equivalent on 2009-03-30. Applicant: Vascular Solutions, Inc..

Clearance details

Applicant: Vascular Solutions, Inc.
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2008-12-19
Decision date: 2009-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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.