CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVE— 510(k) K851615

Substantially Equivalent

Centrimed Corp.

FDA 510(k) clearance K851615 for CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVE, Substantially Equivalent on 1985-06-19. Applicant: Centrimed Corp..

Clearance details

Applicant: Centrimed Corp.
Product code: Code DTQ
Advisory panel: Cardiovascular
Date received: 1985-04-19
Decision date: 1985-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkins, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

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.