NVM · Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
Cardiovascular · 21 CFR 870.1250 · Class 2
Overview
| Product Code | NVM |
|---|---|
| Device Name | Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
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).
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K213915 | BIB Stent Placement Catheter | NuMED, Inc. | Jan 12, 2022 | SESE |
| K211134 | BIB Stent Placement Catheter | NuMED, Inc. | May 27, 2021 | SESE |
| K161451 | BIB Stent Placement Catheter | NuMED, Inc. | Sep 22, 2016 | SESE |
| K160889 | BIB Stent Placement Catheter | NuMED, Inc. | May 20, 2016 | SESE |
| K050857 | BIB PTA BALLOON CATHETER | NuMED, Inc. | Jul 28, 2005 | SESU |
Top Applicants
- NuMED, Inc. — 5 clearances
