Device Classification Name |
catheter, continuous flush
|
510(k) Number |
K211110 |
Device Name |
Agile Devices Angler Steerable, Deflectable Microcatheter |
Applicant |
Agile Devices, Inc. |
69 Fox Hill Road |
Wellesley,
MA
02481
|
|
Applicant Contact |
Stephen Tully |
Correspondent |
Strategic Device Solutions LLC |
20 Lawton Lane |
Foxborough,
MA
02035
|
|
Correspondent Contact |
Stephen Tully |
Regulation Number | 870.1210
|
Classification Product Code |
|
Date Received | 04/14/2021 |
Decision Date | 01/07/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|