510(k) K101385

DUAL LUER LOCK CAP, MODEL 2C6250 by Baxter Healthcare Corp — Product Code FPA

K101385 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "DUAL LUER LOCK CAP, MODEL 2C6250". The FDA issued a decision of Substantially Equivalent on June 22, 2010. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2010
Date Received
May 18, 2010
Clearance Type
Special
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