R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005

Device Classification Name

catheter,intravascular,therapeutic,long-term greater than 30 days

510(k) Number K071361
Device Name R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005
Applicant
R4 VASCULAR, INC.
1246 university avenue west
suite 438
st. paul, 
MN 
55104

Applicant Contact michael sarajian
Correspondent
R4 VASCULAR, INC.
1246 university avenue west
suite 438
st. paul, 
MN 
55104

Correspodent Contact michael sarajian
Regulation Number 880.5970
Classification Product Code
LJS  
Date Received 05/15/2007
Decision Date 08/20/2007
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