VITAL 5 RELEAF CATHETER— 510(k) K122661

Substantially Equivalent

Vital 5

FDA 510(k) clearance K122661 for VITAL 5 RELEAF CATHETER, Substantially Equivalent on 2013-02-27. Applicant: Vital 5.

Clearance details

Applicant: Vital 5
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 2012-08-31
Decision date: 2013-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Logan, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.