INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,


Device Classification Name

set, administration, intravascular

510(k) Number K103551
Device Name INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,
Applicant
BAXTER HEALTHCARE CORP.
1620 waukegan road
mcgaw park, 
IL 
60085

Applicant Contact nanette hedden
Correspondent
BAXTER HEALTHCARE CORP.
1620 waukegan road
mcgaw park, 
IL 
60085

Correspodent Contact nanette hedden
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 12/02/2010
Decision Date 03/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls