ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM— 510(k) K961287

Substantially Equivalent

Rocket Medical Plc

FDA 510(k) clearance K961287 for ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM, Substantially Equivalent on 1996-07-26. Applicant: Rocket Medical Plc.

Clearance details

Applicant: Rocket Medical Plc
Product code: Code KDQ
Advisory panel: General Hospital
Date received: 1996-04-03
Decision date: 1996-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, Tyne & Wear, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDQ

product code KDQ

Death: 8
Malfunction: 637
Total: 645

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.