Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K102725 |
Device Name |
CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M |
Applicant |
BRIDGE MEDICAL, INC. |
2800 CAMPUS DR |
SUITE 50 |
PLYMOUTH,
MN
55441
|
|
Applicant Contact |
JILL MUNSINGER |
Correspondent |
BRIDGE MEDICAL, INC. |
2800 CAMPUS DR |
SUITE 50 |
PLYMOUTH,
MN
55441
|
|
Correspondent Contact |
JILL MUNSINGER |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/21/2010 |
Decision Date | 05/10/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|