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U.S. Department of Health and Human Services

Product Classification
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Device reprocessed atherectomy catheter
Regulation Description Intraluminal artery stripper.
Definition Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission
Physical State Reprocessed Single Use Catheter with laser or mechanical cutting/shaving mechanism
Technical Method Use of mechanical or laser energy to remove plaque in a lesion of the vessel
Target Area Peripheral arteries
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQTF
Premarket Review Coronary and Peripheral Interventional Devices (DHT2C)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.4875
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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