BIO-MATE(TM) EPIDURAL CATHETER— 510(k) K884969

Substantially Equivalent

Medevice, Inc.

FDA 510(k) clearance K884969 for BIO-MATE(TM) EPIDURAL CATHETER, Substantially Equivalent on 1989-06-23. Applicant: Medevice, Inc..

Clearance details

Applicant: Medevice, Inc.
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 1988-11-30
Decision date: 1989-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada L4w 4m2, CA

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.