THE PICC WAND (R) PEELABLE SAFETY INTRODUCER


Device Classification Name

introducer, catheter

510(k) Number K111138
Device Name THE PICC WAND (R) PEELABLE SAFETY INTRODUCER
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 04/22/2011
Decision Date 06/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No