ARSTASIS DILATOR ADAPTER


Device Classification Name

dilator, vessel, for percutaneous catheterization

510(k) Number K103421
Device Name ARSTASIS DILATOR ADAPTER
Applicant
ARSTASIS, INC.
1021 howard ave
suite c
san carlos, 
CA 
94070

Applicant Contact debra cogan
Correspondent
ARSTASIS, INC.
1021 howard ave
suite c
san carlos, 
CA 
94070

Correspodent Contact debra cogan
Regulation Number 870.1310
Classification Product Code
DRE  
Date Received 11/22/2010
Decision Date 05/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No