X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1


information about

Device Classification Name

introducer, catheter

510(k) Number K002054
Device Name X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1
Original Applicant
APPRIVA MEDICAL, INC.
777 north pastoria ave.
sunnyvale, 
CA 
94086

Original Contact michael kolber
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 07/06/2000
Decision Date 02/16/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No