TRANSRADIAL ARTERY ACCESS DEVICES


Device Classification Name

introducer, catheter

510(k) Number K112554
Device Name TRANSRADIAL ARTERY ACCESS DEVICES
Applicant
Teleflex Medical, Inc.
2400 bernville road
reading, 
PA 
19605

Applicant Contact christine ford
Correspondent
Teleflex Medical, Inc.
2400 bernville road
reading, 
PA 
19605

Correspodent Contact christine ford
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 09/02/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls