510(k) K131478

CONTRAST CONSERVATION SYSTEM by Osprey Medical, Inc. — Product Code DXT

K131478 is an FDA 510(k) premarket notification submitted by Osprey Medical, Inc. for the device "CONTRAST CONSERVATION SYSTEM". The FDA issued a decision of Substantially Equivalent on Aug 15, 2013. 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
Aug 15, 2013
Date Received
May 22, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type