inforMED
DWDClass II

Suction Control, Intracardiac, Cardiopulmonary Bypass

Cardiovascular · 21 CFR 870.4430

MDR events108All time
Recalls0All time
Registered firms9Currently listed
510(k) clearances15All time

Recent MDR events

108 adverse event reports on file

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Event type breakdown

Malfunction75
Injury30
Other3

Most-reported manufacturers

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Quest Medical, Inc.67Quest Medical, Inc26Deroyal Industries, Inc.3Medtronic Mexico S. De R.l. De Cv2Unspecified1Cardioquip, Llc1Chirurgische Instrumente1Deroyal1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

9 firms currently registered for this product code

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510(k) clearances

15 clearances for this product code

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