SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS


Device Classification Name

introducer, catheter

510(k) Number K112407
Device Name SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS
Applicant
SMITHS MEDICAL MD, INC.
1265 grey fox rd.
st. paul, 
MN 
55112

Applicant Contact tom bliss
Correspondent
SMITHS MEDICAL MD, INC.
1265 grey fox rd.
st. paul, 
MN 
55112

Correspodent Contact tom bliss
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 08/22/2011
Decision Date 02/09/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No