BIB Stent Placement Catheter
FDA 510(k) clearance K213915 · decided 2022-01-12
Clearance details
- K-number
- K213915
- Device name
- BIB Stent Placement Catheter
- Applicant
- NuMED, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-15
- Decision date
- 2022-01-12
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- NVM
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hopkinton, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BIB Stent Placement Catheter (K211134) | NuMED, Inc. | 2021-05-27 |
| BIB Stent Placement Catheter (K161451) | NuMED, Inc. | 2016-09-22 |
| BIB Stent Placement Catheter (K160889) | NuMED, Inc. | 2016-05-20 |
| BIB PTA BALLOON CATHETER (K050857) | NuMED, Inc. | 2005-07-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| G-Armor Stent, G-Armor Covered Stent, G-Armor Mounted Stent, G-Armor Covered Mounted Stent (P150028/S006) | NuMED, Inc. | 2021-12-13 |
| NuDEL Delivery System (P150028/S005) | NuMED, Inc. | 2021-07-28 |
| CP Stent, Covered CP Stent, Mounted CP Stent, Covered and Mounted CP Stent, Mounted CP Stent, NuDEL (P150028/S004) | NuMED, Inc. | 2019-12-19 |
| NuDel Delivery System (P150028/S002) | NuMED, Inc. | 2018-11-14 |
| Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) (P150028/S003) | NuMED, Inc. | 2018-07-20 |
| Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) (P150028/S001) | NuMED, Inc. | 2017-10-24 |
| CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) (P150028) | NuMED, Inc. | 2016-03-25 |