SMARTWIRE/SMARTMAP PRESSURE SYSTEM


Device Classification Name

wire, guide, catheter

510(k) Number K021219
Device Name SMARTWIRE/SMARTMAP PRESSURE SYSTEM
Original Applicant
JOMED, INC.
2870 kilgore rd.
rancho cordova, 
CA 
95670

Original Contact terry schultz
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 04/17/2002
Decision Date 05/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No