BIB Stent Placement Catheter
FDA 510(k) K211134 · NuMED, Inc.
510(k) numberK211134
Submission
- Device name
- BIB Stent Placement Catheter
- Applicant
- NuMED, Inc.
Hopkinton, NY, US - Received
- April 16, 2021
- Decision date
- May 27, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NVM – Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries
Other 510(k)s with product code NVM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213915 | BIB Stent Placement CatheterNVM · Special | NuMED, Inc. | 01/12/2022SE |
| K161451 | BIB Stent Placement CatheterNVM · Traditional | NuMED, Inc. | 09/22/2016SE |
| K160889 | BIB Stent Placement CatheterNVM · Traditional | NuMED, Inc. | 05/20/2016SE |
| K050857 | Bib Pta Balloon CatheterNVM · Traditional | NuMED, Inc. | 07/28/2005SESU |
More from NuMED, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K213915 | BIB Stent Placement CatheterNVM · Special | 01/12/2022SE |
| K211910 | Z-6 Atrioseptostomy CatheterDXF · Special | 07/19/2021SE |
| K190974 | D'Vill IntroducerDYB · Special | 05/14/2019SE |
| K171206 | D'Vill IntroducerDYB · Traditional | 10/20/2017SE |
| K161451 | BIB Stent Placement CatheterNVM · Traditional | 09/22/2016SE |
| K160598 | REBOA Balloon CatheterMJN · Traditional | 06/20/2016SE |
| K160889 | BIB Stent Placement CatheterNVM · Traditional | 05/20/2016SE |
| K131869 | Pts-X Sizing Balloon CatheterMJN · Special | 08/08/2013SE |
| K122012 | Z-Med Z-Med IIOZT · Traditional | 10/04/2012SE |
| K121859 | Tyshak NucleusDQY · Special | 08/31/2012SE |
Questions and answers
When was BIB Stent Placement Catheter cleared by the FDA?
BIB Stent Placement Catheter (K211134) received a 510(k) decision of Substantially Equivalent on May 27, 2021, 41 days after the submission was received.
What is the product code of K211134?
The FDA product code is NVM – Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon, a Class II (moderate risk) device regulated under 21 CFR 870.1250.