PATHWAY PV ATHERECTOMY SYSTEM


Device Classification Name

catheter, peripheral, atherectomy

510(k) Number K081328
Device Name PATHWAY PV ATHERECTOMY SYSTEM
Applicant
PATHWAY MEDICAL TECHNOLOGIES, INC.
10801 120th avenue ne
kirkland, 
WA 
98033

Applicant Contact brian cleary
Correspondent
PATHWAY MEDICAL TECHNOLOGIES, INC.
10801 120th avenue ne
kirkland, 
WA 
98033

Correspodent Contact brian cleary
Regulation Number 870.4875
Classification Product Code
MCW  
Date Received 05/12/2008
Decision Date 07/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No