Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K053268 |
Device Name |
PVS 2000 SYNCHRO2 GUIDEWIRE |
Applicant |
BOSTON SCIENTIFIC - PRECISION VASCULAR |
2405 WEST ORTON CIR. |
WEST VALLEY CITY,
UT
84119
|
|
Applicant Contact |
RICK GAYKOWSKI |
Correspondent |
BOSTON SCIENTIFIC - PRECISION VASCULAR |
2405 WEST ORTON CIR. |
WEST VALLEY CITY,
UT
84119
|
|
Correspondent Contact |
RICK GAYKOWSKI |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 11/23/2005 |
Decision Date | 03/13/2006 |
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
|
|
|