510(k) K060074

INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326 by Baxter Healthcare Corp — Product Code FPA

K060074 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326". The FDA issued a decision of Substantially Equivalent on Mar 29, 2006. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 29, 2006
Date Received
Jan 10, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type
510(k)

Source: FDA 510(k) database entry for K060074. Report a data issue: hello@regdatalab.com.