510(k) K200373

Deltaven Fast Flash Closed I.V. Catheter Systems by Delta Med Spa — Product Code FOZ

K200373 is an FDA 510(k) premarket notification submitted by Delta Med Spa for the device "Deltaven Fast Flash Closed I.V. Catheter Systems". The FDA issued a decision of Substantially Equivalent on August 26, 2020. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Delta Med Spa has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2020
Date Received
February 14, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type