510(k) K212027
K212027 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "TurboHawk Plus Directional Atherectomy System". The FDA issued a decision of Substantially Equivalent on Aug 24, 2021. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Medtronic, Inc. has 247 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 24, 2021
- Date Received
- Jun 29, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Peripheral, Atherectomy
- Device Class
- Class II
- Regulation Number
- 870.4875
- Review Panel
- CV
- Submission Type
- 510(k)