LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit— 510(k) K200795
Substantially EquivalentMedtronic, Inc.
FDA 510(k) clearance K200795 for LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit, Substantially Equivalent on 2020-07-03. Applicant: Medtronic, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic, Inc.
- Product code
- Code MXD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mounds View, MN, US
Recent devices under product code MXD
view all- K262735 — LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
- K261074 — BIOMONITOR IV (471155)
- K253516 — Assert-IQ (DM5100)
- K251221 — Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)
- K252593 — LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)
More clearances from Medtronic, Inc.
view allAdverse events under product code MXD
product code MXD- Injury
- 1,880
- Malfunction
- 9,487
- Total
- 11,367
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K200795
K-number listed on FDA's recall record- Z-0421-2024 — ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
- Z-0782-2022 — LINQ II Insertable Cardiac Monitor
- Z-2076-2021 — Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200795.
Data sourced from openFDA. This site is unofficial and independent of the FDA.