MULTICROSS SUPPORT CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K121763
Device Name MULTICROSS SUPPORT CATHETER
Applicant
ROXWOOD MEDICAL, INC.
150 executive park blvd, ste 3700
san francisco, 
CA 
94134

Applicant Contact mehrdad farhangnia
Correspondent
ROXWOOD MEDICAL, INC.
150 executive park blvd, ste 3700
san francisco, 
CA 
94134

Correspodent Contact mehrdad farhangnia
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 06/15/2012
Decision Date 11/27/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No