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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, balloon, intra-aortic and control, reprocessed
Definition Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product CodeNKO
Regulation Number 870.3535
Device Class 3

MDR Year MDR Reports MDR Events
2016 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Hole In Material 1 1
Battery Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1 1
Insufficient Information 1 1

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