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FDA 510(k), K211304, LINQ II Insertable Cardiac Monitor
FDA 510(k), K211304, LINQ II Insertable Cardiac Monitor
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510(K) Number: K211304
Device Name: LINQ II Insertable Cardiac Monitor
Manufacturer: Medtronic, Inc.
Device Classification Name: recorder, event, implantable cardiac, (with arrhythmia detection)
Regulation Number: 870.1025
Classification Product Code: MXD
Date Received: 04/29/2021
Decision Date: 05/28/2021
Regulation Medical Specialty: Cardiovascular
Device Name: LINQ II Insertable Cardiac Monitor
Manufacturer: Medtronic, Inc.
Device Classification Name: recorder, event, implantable cardiac, (with arrhythmia detection)
Regulation Number: 870.1025
Classification Product Code: MXD
Date Received: 04/29/2021
Decision Date: 05/28/2021
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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