21 CFR 870.1250 — Catheter, Percutaneous

Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1250

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
DQYCatheter, Percutaneous28893rd Party
LITCatheter, Angioplasty, Peripheral, Transluminal24033rd Party
NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection222
NMMCatheter, Angioplasty, Peripheral, Transluminal, Reprocessed20
NRYCatheter, Thrombus Retriever2108
NTETemporary Carotid Catheter For Embolic Capture236
NVMCatheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon253rd Party
OFKPercutaneous Atrial Catheter Kit20
OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter25
PDUCatheter For Crossing Total Occlusions257
PNOCatheter, Percutaneous, Cutting/Scoring245
PPNPercutaneous Catheter, Ultrasound212
QJPCatheter, Percutaneous, Neurovasculature291
Innolitics

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