VIAPEEL PEELABLE INTRODUCER


Device Classification Name

introducer, catheter

510(k) Number K072248
Device Name VIAPEEL PEELABLE INTRODUCER
Applicant
ENPATH MEDICAL, INC.
2300 berkshire lane north
minneapolis, 
MN 
55441

Applicant Contact patrice stromberg
Correspondent
ENPATH MEDICAL, INC.
2300 berkshire lane north
minneapolis, 
MN 
55441

Correspodent Contact patrice stromberg
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 08/13/2007
Decision Date 11/09/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No