NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC

Device Classification Name

introducer, catheter

510(k) Number K034025
Device Name NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC
Applicant
NMT MEDICAL, INC.
27-43 wormwood st.
boston, 
MA 
02210

Applicant Contact anne m kulis
Correspondent
NMT MEDICAL, INC.
27-43 wormwood st.
boston, 
MA 
02210

Correspodent Contact anne m kulis
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 12/29/2003
Decision Date 03/26/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No