Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K103367 |
Device Name |
SEEKER CROSSING SUPPORT CATHETER |
Applicant |
BARD PERIPHERAL VASCULAR, INC. |
1415 WEST 3RD ST. |
TEMPE,
AZ
85281
|
|
Applicant Contact |
CANDACE WADE |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 11/16/2010 |
Decision Date | 12/08/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|