MEDCOMP VASCU-SHEATH INTRODUCER SET


Device Classification Name

introducer, catheter

510(k) Number K022513
Device Name MEDCOMP VASCU-SHEATH INTRODUCER SET
Original Applicant
MEDCOMP
1499 delp dr.
harleysville, 
PA 
19438

Original Contact florence a caikoski
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 07/30/2002
Decision Date 10/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No