SHEATH ADAPTER, MODEL SA-09847


Device Classification Name

introducer, catheter

510(k) Number K021723
Device Name SHEATH ADAPTER, MODEL SA-09847
Original Applicant
ARROW INTL., INC.
2400 bernville rd.
reading, 
PA 
19605

Original Contact brandon epting
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 05/24/2002
Decision Date 08/08/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No