Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K092455 |
Device Name |
MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM |
Applicant |
Boston Scientific Corporation |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Applicant Contact |
SHANNON PETIT |
Correspondent |
Boston Scientific Corporation |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Correspondent Contact |
SHANNON PETIT |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/10/2009 |
Decision Date | 09/04/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|