The following data is part of a premarket notification filed by Atrility Medical, Llc with the FDA for Atriamp, Atriamp - Pacing Cable Medtronic Connector, Atriamp - Pacing Cable Oscor Connector.
| Device ID | K200674 |
| 510k Number | K200674 |
| Device Name: | AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | Atrility Medical, LLC 313 Price Place, Suite 13 Madison, WI 53705 |
| Contact | Matthew Knoespel |
| Correspondent | Gary Syring Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-16 |
| Decision Date | 2020-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860004773726 | K200674 | 000 |
| 10860004773716 | K200674 | 000 |
| 10860004773709 | K200674 | 000 |