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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device guidewire, catheter, reprocessed
Regulation Description Catheter guide wire.
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 CodeNKQ
Regulation Number 870.1330
Device Class 2

MDR Year MDR Reports MDR Events
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Vascular I Jun-16-2021
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