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Parker Quality & Compliance

PQC Reg Watch

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Device type

Catheter For Crossing Total Occlusions

Product code PDU · Class II · 21 CFR 870.1250 · Cardiovascular

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.

FDA classification database

Recent 510(k)s

Recent recalls

No recalls in the archive for PDU.