Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
The Dual-Balloon Peripheral Transluminal Angioplasty Catheter is a cardiovascular device used for percutaneous transluminal angioplasty of peripheral vasculature exclusive of the coronary arteries, using a dual-balloon design to dilate stenotic or occluded vessels. It is an FDA Class 2 device regulated under 21 CFR 870.1250 in the Cardiovascular specialty, with product code NVM, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not carry life-sustaining support designation.
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Basic Information
- Product Code
- NVM
- Device Class
- FDA class 2
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K213915 | BIB Stent Placement Catheter | Jan 12, 2022 | Substantially Equivalent | NuMED, Inc. |
| K211134 | BIB Stent Placement Catheter | May 27, 2021 | Substantially Equivalent | NuMED, Inc. |
| K161451 | BIB Stent Placement Catheter | Sep 22, 2016 | Substantially Equivalent | NuMED, Inc. |
| K160889 | BIB Stent Placement Catheter | May 20, 2016 | Substantially Equivalent | NuMED, Inc. |
| K050857 | BIB PTA BALLOON CATHETER | Jul 28, 2005 | Unknown | NuMED, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.