Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K131300 |
Device Name |
THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER |
Applicant |
ACCESS SCIENTIFIC, LLC |
3910 Sorrento Valley Blvd Ste 200 |
San Diego,
CA
92121
|
|
Applicant Contact |
ALBERT MISAJON |
Correspondent |
ACCESS SCIENTIFIC, LLC |
3910 Sorrento Valley Blvd Ste 200 |
San Diego,
CA
92121
|
|
Correspondent Contact |
ALBERT MISAJON |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 05/07/2013 |
Decision Date | 06/07/2013 |
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
|
|
|