LINQ II Insertable Cardiac Monitor

Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Linq Ii Insertable Cardiac Monitor.

Pre-market Notification Details

• Device ID: K221962
• 510k Number: K221962
• Device Name: LINQ II Insertable Cardiac Monitor
• Classification: Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
• Applicant: Medtronic, Inc. 8200 Coral Sea Street NE MS-MVS11 Mounds View, MN 55112
• Contact: Dianna L. Johannson
• Correspondent: Dianna L. Johannson; Medtronic, Inc. 8200 Coral Sea Street NE MS-MVS11 Mounds View, MN 55112
• Product Code: MXD
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-07-05
• Decision Date: 2022-08-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00763000613747	K221962	000