DeviceClearance

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. Device class: 2.

Clearance details

Applicant
Cardioquip Llp
Product code
Code DWC
Device class
Class 2
Regulation
21 CFR 870.4250
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bryan, TX, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DWC

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Adverse events under product code DWC

product code DWC
Death
124
Injury
233
Malfunction
3,727
Total
4,084

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K102147

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102147.

Data sourced from openFDA. This site is unofficial and independent of the FDA.