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Cardiovascular devices

304 product codes reviewed by the Cardiovascular panel. 19,231 510(k) clearances and 6,943 recalls in the FDA data, 81% of those recalls name a 510(k).

405510(k)s in 12 months

470recalls in 12 months

5,607recalls that name a 510(k)

Active product codes, Class III

Code	Device	Class	Recalls, 12 mo
MKJ	Automated External Defibrillators (Non-Wearable)	3	4
PYX	Temporary Non-Roller Type Right Heart Support Blood Pump	3	3
PNJ	Leadless Pacemaker	3	1

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