REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)


Device Classification Name

introducer, catheter

510(k) Number K081341
Device Name REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)
Applicant
THOMAS MEDICAL PRODUCTS, INC.
65 great valley pkwy.
malvern, 
PA 
19355

Applicant Contact tim stoudt
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 05/13/2008
Decision Date 05/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No