METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER


Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K024000
Device Name METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER
Original Applicant
ANGIOMETRX INC.
936 11th avenue east
seattle, 
WA 
98102

Original Contact carl youngmann
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 12/04/2002
Decision Date 06/26/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls