510(k) K202620
K202620 is an FDA 510(k) premarket notification submitted by Medtronic Cryocath, LP for the device "FlexCath Advance Steerable Sheath and Dilator". The FDA issued a decision of Substantially Equivalent on November 13, 2020. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Medtronic Cryocath, LP has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 2020
- Date Received
- September 10, 2020
- 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