CATH-GUIDE— 510(k) K955645

Substantially Equivalent

Hudson Respiratory Care, Inc.

FDA 510(k) clearance K955645 for CATH-GUIDE, Substantially Equivalent on 1996-03-12. Applicant: Hudson Respiratory Care, Inc..

Clearance details

Applicant: Hudson Respiratory Care, Inc.
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1995-12-12
Decision date: 1996-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mccordsville, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.