OXYGENATION CATHETER— 510(k) K881881

Substantially Equivalent

Ventech Healthcare Corp., Inc.

FDA 510(k) clearance K881881 for OXYGENATION CATHETER, Substantially Equivalent on 1989-02-17. Applicant: Ventech Healthcare Corp., Inc..

Clearance details

Applicant: Ventech Healthcare Corp., Inc.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1988-05-04
Decision date: 1989-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

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.