CPR SUCTION CATHETER KIT— 510(k) K960216

Substantially Equivalent

Custom Pack Reliability

FDA 510(k) clearance K960216 for CPR SUCTION CATHETER KIT, Substantially Equivalent on 1996-04-15. Applicant: Custom Pack Reliability.

Clearance details

Applicant: Custom Pack Reliability
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1996-01-16
Decision date: 1996-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JOL

product code JOL

Death: 7
Injury: 177
Malfunction: 1,306
Other: 1
Total: 1,491

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.