510(k) K211738
K211738 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Rotarex Atherectomy System". The FDA issued a decision of Substantially Equivalent on September 14, 2021. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2021
- Date Received
- June 7, 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