510(k) K992532

VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING by Baxter Healthcare Corp — Product Code FOZ

K992532 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING". The FDA issued a decision of Substantially Equivalent on Jun 13, 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
Jun 13, 2000
Date Received
Jul 29, 1999
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 K992532. Report a data issue: hello@regdatalab.com.