510(k) K152978
K152978 is an FDA 510(k) premarket notification submitted by Deroyal Industries, Inc. for the device "DeRoyal Angiography Kits". The FDA issued a decision of Substantially Equivalent (kit) on March 25, 2016. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Deroyal Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- March 25, 2016
- Date Received
- October 9, 2015
- Clearance Type
- Traditional
- 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