510(k) K211134
K211134 is an FDA 510(k) premarket notification submitted by NuMED, Inc. for the device "BIB Stent Placement Catheter". The FDA issued a decision of Substantially Equivalent on May 27, 2021. The device falls under product code NVM (Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon), a Class II device regulated under 21 CFR 870.1250. NuMED, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 2021
- Date Received
- April 16, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries