510(k) K984590

0.9% SODIUM CHLORIDE FLUSH SYRINGE by Baxter Healthcare Corp — Product Code FOZ

K984590 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "0.9% SODIUM CHLORIDE FLUSH SYRINGE". The FDA issued a decision of Substantially Equivalent on Oct 7, 1999. 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. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 7, 1999
Date Received
Dec 28, 1998
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
510(k)

Source: FDA 510(k) database entry for K984590. Report a data issue: hello@regdatalab.com.