Device Classification Name |
catheter, intracardiac mapping, high-density array
|
510(k) Number |
K223666 |
Device Name |
Ablacath™ Mapping Catheter |
Applicant |
Ablacon, Inc. |
4800 Wadsworth Blvd Suite 310 |
Wheat Ridge,
CO
80033
|
|
Applicant Contact |
Frank Rodriguez |
Correspondent |
Honkanen Consulting, Inc. |
738 Saddle Wood Drive |
Eagan,
MN
55123
|
|
Correspondent Contact |
Laurie Lewandowski |
Regulation Number | 870.1220
|
Classification Product Code |
|
Date Received | 12/07/2022 |
Decision Date | 03/17/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|