Device Classification Name |
Catheter For Crossing Total Occlusions
|
510(k) Number |
K210664 |
Device Name |
DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) |
Applicant |
Ra Medical Systems, Inc. |
2070 Las Palmas Drive |
Carlsbad,
CA
92011
|
|
Applicant Contact |
Jami Miller |
Correspondent |
Ra Medical Systems, Inc. |
2070 Las Palmas Drive |
Carlsbad,
CA
92011
|
|
Correspondent Contact |
Jami Miller |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 03/05/2021 |
Decision Date | 07/27/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|