CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000— 510(k) K102147

Substantially Equivalent

Cardioquip Llp

FDA 510(k) clearance K102147 for CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000, Substantially Equivalent on 2010-11-19. Applicant: Cardioquip Llp.

Clearance details

Applicant: Cardioquip Llp
Product code: Code DWC
Advisory panel: Cardiovascular
Date received: 2010-07-30
Decision date: 2010-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bryan, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWC

product code DWC

Death: 124
Injury: 233
Malfunction: 3,727
Total: 4,084

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.