THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER


Device Classification Name

introducer, catheter

510(k) Number K111417
Device Name THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
Applicant
ACCESS SCIENTIFIC, INC.
12526 high bluff drive
suite 360
san diego, 
CA 
92130

Applicant Contact albert misajon
Correspondent
ACCESS SCIENTIFIC, INC.
12526 high bluff drive
suite 360
san diego, 
CA 
92130

Correspodent Contact albert misajon
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 05/20/2011
Decision Date 07/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls