FLASH-C PTCA BALLOON DILATION CATHETER – 5MM X 19MM X 135CM / 6MM X 19MM X 135CM


Device Classification Name

catheters, transluminal coronary angioplasty, percutaneous

510(k) Number K111284
Device Name FLASH-C PTCA BALLOON DILATION CATHETER – 5MM X 19MM X 135CM / 6MM X 19MM X 135CM
Applicant
OSTIAL CORPORATION
510 clyde avenue
mountain view, 
CA 
94043

Applicant Contact mark smutka
Correspondent
OSTIAL CORPORATION
510 clyde avenue
mountain view, 
CA 
94043

Correspodent Contact mark smutka
Regulation Number 870.5100
Classification Product Code
LOX  
Date Received 05/06/2011
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 No

Combination Product

No