BANTAM CATHETER (280MM BALLOON LENGTHS)


Device Classification Name

catheter, percutaneous

510(k) Number K112335
Device Name BANTAM CATHETER (280MM BALLOON LENGTHS)
Applicant
CLEAR STREAM TECHNOLOGIES, LTD.
moyne upper, enniscorthy
county wexford, 

IE

Applicant Contact fiona ni mhullain
Regulation Number 870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received 08/12/2011
Decision Date 10/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No