PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL— 510(k) K897194

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K897194 for PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL, Substantially Equivalent on 1990-06-18. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 1989-12-29
Decision date: 1990-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, 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.