510(k) K163084
K163084 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Merit Coronary Control Syringe". The FDA issued a decision of Substantially Equivalent on Jun 15, 2017. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Merit Medical Systems, Inc. has 180 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 15, 2017
- Date Received
- Nov 3, 2016
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector And Syringe, Angiographic
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- HO
- Submission Type
- 510(k)