Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K131225 |
Device Name |
ADROIT GUIDING CATHETER |
Applicant |
CORDIS CORP., A JOHNSON & JOHNSON CO. |
6500 PASEO PADRE PKWY. |
FREMONT,
CA
94555
|
|
Applicant Contact |
MARY E HOLDEN |
Correspondent |
CORDIS CORP., A JOHNSON & JOHNSON CO. |
6500 PASEO PADRE PKWY. |
FREMONT,
CA
94555
|
|
Correspondent Contact |
MARY E HOLDEN |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 04/30/2013 |
Decision Date | 05/29/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|