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U.S. Department of Health and Human Services

Product Classification
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Device catheter for crossing total occlusions
Regulation Description Percutaneous catheter.
Definition To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.
Physical State Peripheral catheter
Technical Method Creates narrow channel in occlusion to allow for guidewire placement for further percutaneous intervention, such as angioplasty, atherectomy or stent placement.
Target Area Peripheral vasculature
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePDU
Premarket Review Coronary and Peripheral Interventional Devices (DHT2C)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.1250
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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