510(k) K183267
K183267 is an FDA 510(k) premarket notification submitted by Osprey Medical, Inc. for the device "DyeVert NG Contrast Reduction System, DyeVert PLUS EZ Contrast Reduction System, DyeTect Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert PLUS EZ Contrast Reduction System". The FDA issued a decision of Substantially Equivalent on December 20, 2018. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Osprey Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2018
- Date Received
- November 23, 2018
- Clearance Type
- Special
- 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