Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K121748 |
Device Name |
THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL |
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
|
|
Correspondent Contact |
ALBERT MISAJON |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 06/14/2012 |
Decision Date | 07/27/2012 |
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
|
|
|