JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM


Device Classification Name

catheter, peripheral, atherectomy

510(k) Number K110626
Device Name JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L 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 03/04/2011
Decision Date 04/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No