LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application— 510(k) K230553
Substantially EquivalentMedtronic, Inc.
FDA 510(k) clearance K230553 for LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application, Substantially Equivalent on 2023-04-26. 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 K230553
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K230553.
Data sourced from openFDA. This site is unofficial and independent of the FDA.