DISPOSABLE TEMPORARY PACING WIRE


Device Classification Name

electrode, pacemaker, temporary

510(k) Number K023174
Device Name DISPOSABLE TEMPORARY PACING WIRE
Original Applicant
RIVER MEDICAL, INC.
836 ne 24th ave.
portland, 
OR 
97232

Original Contact mary ann greenawalt
Regulation Number 870.3680
Classification Product Code
LDF  
Date Received 09/23/2002
Decision Date 06/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No