NRG TRANSSEPTAL NEEDLE


Device Classification Name

catheter, septostomy

510(k) Number K073326
Device Name NRG TRANSSEPTAL NEEDLE
Applicant
BAYLIS MEDICAL CO., INC.
2645 matheson blvd. e
mississauga, ontario, 

CA

l4w 5s4

Applicant Contact meghal khakhar
Correspondent
BAYLIS MEDICAL CO., INC.
2645 matheson blvd. e
mississauga, ontario, 

CA

l4w 5s4

Correspodent Contact meghal khakhar
Regulation Number 870.5175
Classification Product Code
DXF  
Date Received 11/27/2007
Decision Date 05/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No