510(k) K203487
K203487 is an FDA 510(k) premarket notification submitted by Accurate Medical Therapeutics, Ltd. for the device "Drakon and Sequre Microcatheters". The FDA issued a decision of Substantially Equivalent on December 11, 2020. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Accurate Medical Therapeutics, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2020
- Date Received
- November 27, 2020
- Clearance Type
- Special
- 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