510(k) K233320

Device: LINQ II? Insertable Cardiac Monitor (LNQ22)
Applicant: Medtronic, Inc.
510(k) number: K233320
Product code: MXD
Decision: Substantially Equivalent (SESE)
Decision date: 2023-10-31
Date received: 2023-09-29
Regulation: 870.1025
Classification name: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: Dustin Hawbaker
Address: Cardiovascular Diagnostics And Services 8200 Coral Sea St. NE Mounds View MN US 55112 55112

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00763000613747	LINQ II™	MEDTRONIC, INC.	2023-11-19

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K261074	BIOMONITOR IV (471155)	Biotronik, Inc.	2026-05-01
K253516	Assert-IQ (DM5100)	ABBOTT MEDICAL	2025-12-18
K251221	Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)	Abbott	2025-09-17
K252593	LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)	Boston Scientific Corporation	2025-09-12
K240693	LINQ II™ Insertable Cardiac Monitor (ICM)	Medtronic, Inc.	2024-03-28
K233562	LINQ II Insertable Cardiac Monitor	Medtronic, Inc.	2023-12-06
K231328	LUX-Dx II (M302); LUX-Dx II+ (M312)	Boston Scientific Corp	2023-08-19
K230375	BIOMONITOR IV	Biotronik, Inc.	2023-05-19
K230553	LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application	Medtronic, Inc.	2023-04-26
K223630	Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System	Medtronic, Inc.	2023-04-05
K221962	LINQ II Insertable Cardiac Monitor	Medtronic, Inc.	2022-08-25
K221856	BIOMONITOR IIIm, BIOMONITOR III	Biotronik, Inc.	2022-07-27
K212008	Reveal LINQ Insertable Cardiac Monitor	Medtronic, Inc.	2021-07-22
K210484	LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System	Medtronic, Inc.	2021-06-11
K211304	LINQ II Insertable Cardiac Monitor	Medtronic, Inc.	2021-05-28