510(k) K213631
K213631 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Chocolate PTA Balloon Catheter". The FDA issued a decision of Substantially Equivalent on Dec 15, 2021. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Medtronic, Inc. has 247 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 15, 2021
- Date Received
- Nov 17, 2021
- Clearance Type
- Special
- 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)