PTFE INTERLOCK PEELABLE INTRODUCERS


Device Classification Name

introducer, catheter

510(k) Number K081394
Device Name PTFE INTERLOCK PEELABLE INTRODUCERS
Applicant
ENPATH MEDICAL, INC.
2300 berkshire lane north
minneapolis, 
MN 
55441

Applicant Contact shannon springer
Correspondent
ENPATH MEDICAL, INC.
2300 berkshire lane north
minneapolis, 
MN 
55441

Correspodent Contact shannon springer
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 05/19/2008
Decision Date 09/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No