SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K072947
Device Name SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS
Applicant
CLEARSTREAM TECHNOLOGIES, LTD.
1705 s. capital of texas hwy
suite 500
austin, 
TX 
78746

Applicant Contact ian p gordon
Correspondent
CLEARSTREAM TECHNOLOGIES, LTD.
1705 s. capital of texas hwy
suite 500
austin, 
TX 
78746

Correspodent Contact ian p gordon
Regulation Number 870.1250
Classification Product Code
LIT  
Date Received 10/18/2007
Decision Date 02/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No