510(k) K201246
K201246 is an FDA 510(k) premarket notification submitted by Qualimed USA, LLC for the device "PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)". The FDA issued a decision of Substantially Equivalent on Aug 3, 2021. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 2021
- Date Received
- May 8, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Angioplasty, Peripheral, Transluminal
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)