Device Classification Name |
introducer, catheter
|
510(k) Number |
K160721 |
Device Name |
Vado Steerable Sheath |
Applicant |
KALILA MEDICAL, INC. |
745 CAMDEN AVE, SUITE A |
CAMPBELL,
CA
95008
|
|
Applicant Contact |
Carrie Neuberger |
Correspondent |
KALILA MEDICAL, INC. |
745 CAMDEN AVE, SUITE A |
CAMPBELL,
CA
95008
|
|
Correspondent Contact |
Carrie Neuberger |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 03/16/2016 |
Decision Date | 03/07/2017 |
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
|
|
|