Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K231293 |
Device Name |
Drakon™ and Sequre® Microcatheters |
Applicant |
Accurate Medical Therapeutics |
19 Eli Hurvitz Street |
Rehovot,
IL
7608802
|
|
Applicant Contact |
Osnat Harbater |
Correspondent |
Accurate Medical Therapeutics |
19 Eli Hurvitz Street |
Rehovot,
IL
7608802
|
|
Correspondent Contact |
Osnat Harbater |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 05/04/2023 |
Decision Date | 06/01/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|