IO-FLEX CATHETER— 510(k) K102594

Substantially Equivalent

Baxano, Inc.

FDA 510(k) clearance K102594 for IO-FLEX CATHETER, Substantially Equivalent on 2011-01-19. Applicant: Baxano, Inc..

Clearance details

Applicant: Baxano, Inc.
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 2010-09-09
Decision date: 2011-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, 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.