510(k) K200674
K200674 is an FDA 510(k) premarket notification submitted by Atrility Medical, LLC for the device "AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector". The FDA issued a decision of Substantially Equivalent on July 2, 2020. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2020
- Date Received
- March 16, 2020
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cable, Transducer And Electrode, Patient, (Including Connector)
- Device Class
- Class II
- Regulation Number
- 870.2900
- Review Panel
- CV
- Submission Type