510(k) K190167
K190167 is an FDA 510(k) premarket notification submitted by Abbott for the device "MitraClip G4 Steerable Guide Catheter". The FDA issued a decision of Substantially Equivalent on May 29, 2019. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Abbott has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 2019
- Date Received
- January 31, 2019
- Clearance Type
- Special
- 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