Device Classification Name |
Cable, Transducer And Electrode, Patient, (Including Connector)
|
510(k) Number |
K200674 |
Device Name |
AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector |
Applicant |
Atrility Medical, LLC |
313 Price Place, Suite 13 |
Madison,
WI
53705
|
|
Applicant Contact |
Matthew Knoespel |
Correspondent |
Quality & Regulatory Associates, LLC |
800 Levanger Lane |
Stoughton,
WI
53589
|
|
Correspondent Contact |
Gary Syring |
Regulation Number | 870.2900
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/16/2020 |
Decision Date | 07/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|