510(k) K152310
K152310 is an FDA 510(k) premarket notification submitted by Cardiofocus, Inc. for the device "HeartLight Deflectable Sheath". The FDA issued a decision of Substantially Equivalent on February 24, 2016. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Cardiofocus, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 2016
- Date Received
- August 14, 2015
- 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