510(k) K192019
K192019 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1". The FDA issued a decision of Substantially Equivalent on Nov 8, 2019. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. ABBOTT MEDICAL has 59 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 8, 2019
- Date Received
- Jul 29, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
- 510(k)