CROSSER RECANALIZATION SYSTEM


Device Classification Name

catheter for crossing total occlusions

510(k) Number K112308
Device Name CROSSER RECANALIZATION SYSTEM
Applicant
C.R. BARD, INC.
745 n. pastoria ave
sunnyvale, 
CA 
94085

Applicant Contact timothy wade
Regulation Number 870.1250
Classification Product Code
PDU  
Date Received 08/11/2011
Decision Date 08/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No