21 CFR 870.5150 — Catheter, Embolectomy

Cardiovascular (CV) · Part 870 Subpart F—Cardiovascular Therapeutic Devices · § 870.5150

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
DXECatheter, Embolectomy2743rd Party
MMXDevice, Percutaneous Retrieval2323rd Party
QEWPeripheral Mechanical Thrombectomy With Aspiration2141
QEXCoronary Mechanical Thrombectomy With Aspiration23
QEYMechanical Thrombolysis Catheter271
QEZAspiration Thrombectomy Catheter292
Innolitics

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