510(k) K003245

HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML by Baxter Healthcare Corp — Product Code FOZ

K003245 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML". The FDA issued a decision of Substantially Equivalent on Dec 4, 2000. 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
Dec 4, 2000
Date Received
Oct 17, 2000
Clearance Type
Special
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 K003245. Report a data issue: hello@regdatalab.com.