ONSET ACCESS CATHETER SYSTEM


Device Classification Name

catheter, percutaneous

510(k) Number K112629
Device Name ONSET ACCESS CATHETER SYSTEM
Applicant
ONSET MEDICAL CORPORATION
13900 alton parkway, suite 120
irvine, 
CA 
92618

Applicant Contact joseph bishop
Correspondent
ONSET MEDICAL CORPORATION
13900 alton parkway, suite 120
irvine, 
CA 
92618

Correspodent Contact joseph bishop
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 09/09/2011
Decision Date 10/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No