Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K120881 |
Device Name |
MANTARAY GUIDEWIRES |
Applicant |
BRIDGEPOINT MEDICAL |
13355 10TH AVE N, |
SUITE #110 |
PLYMOUTH,
MN
55441
|
|
Applicant Contact |
JILL MUNSINGER |
Correspondent |
BRIDGEPOINT MEDICAL |
13355 10TH AVE N, |
SUITE #110 |
PLYMOUTH,
MN
55441
|
|
Correspondent Contact |
JILL MUNSINGER |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 03/23/2012 |
Decision Date | 04/18/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|