510(k) K232321
K232321 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "FlexCath Contour Steerable Sheath". The FDA issued a decision of Substantially Equivalent on October 31, 2023. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Medtronic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2023
- Date Received
- August 3, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Steerable
- Device Class
- Class II
- Regulation Number
- 870.1280
- Review Panel
- CV
- Submission Type