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Catheter For Crossing Total Occlusions

FDA product code PDU · 53 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.1250
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2003-01-23 – 2026-08-28

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.

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