SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514— 510(k) K022489

Substantially Equivalent

Summit Medical , Ltd.

FDA 510(k) clearance K022489 for SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514, Substantially Equivalent on 2002-10-09. Applicant: Summit Medical , Ltd..

Clearance details

Applicant: Summit Medical , Ltd.
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 2002-07-29
Decision date: 2002-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stevenage Hertfordshire, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

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.