PDU · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1250
Classification
FDA Product Code
PDU
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.1250
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.