EPIDURAL CATHETER— 510(k) K840202

Substantially Equivalent

Aries Medical, Inc.

FDA 510(k) clearance K840202 for EPIDURAL CATHETER, Substantially Equivalent on 1984-02-27. Applicant: Aries Medical, Inc..

Clearance details

Applicant
Aries Medical, Inc.
Product code
Code BSO
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code BSO

product code BSO
Malfunction
688
Total
688

Source: openFDA MAUDE database, through . 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.