21 CFR 870.1290 — System, Catheter Control, Steerable

Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1290

Identification

A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
DXXSystem, Catheter Control, Steerable2333rd Party
NDQSystem, Catheter Or Guidewire, Steerable (Magnetic)22
NKRSystem, Catheter Control, Reprocessed203rd Party
Innolitics

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