JETSTREAM G3 (R) SF 1.6 SYSTEM


Device Classification Name

catheter, peripheral, atherectomy

510(k) Number K111229
Device Name JETSTREAM G3 (R) SF 1.6 SYSTEM
Applicant
PATHWAY MEDICAL TECHNOLOGIES, INC.
10801 120th avenue ne
kirkland, 
WA 
98033

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

Correspodent Contact cyndy adams
Regulation Number 870.4875
Classification Product Code
MCW  
Date Received 05/02/2011
Decision Date 06/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Clinical Trials NCT00676494
Reviewed by Third Party No

Combination Product

No