FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LINQ II Insertable Cardiac Monitor
K Number: K211304
·
Decision May 28, 2021
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
28
Applicant Total
57
Review Days
29
Basic Information
- Device Name
- LINQ II Insertable Cardiac Monitor
- K Number
- K211304
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- April 29, 2021
- Decision Date
- May 28, 2021
- Product Code
- MXD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MXD | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MXD), ordered by most recent decision date.
LINQ II Insertable Cardiac Monitor (ICM)
FDA 510(k)
FDA Class 2
·Cardiovascular
LINQ II Insertable Cardiac Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
LINQ II Insertable Cardiac Monitor (LNQ22)
FDA 510(k)
FDA Class 2
·Cardiovascular
LUX-Dx II (M302); LUX-Dx II+ (M312)
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOMONITOR IV
FDA 510(k)
FDA Class 2
·Cardiovascular
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Medtronic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) | Mar 27, 2025 | Substantially Equivalent |
| K243892 | Affera Integrated Mapping System | Jan 17, 2025 | Substantially Equivalent |
| K243435 | Magnetic Localization Patch Kit (AFR-00021) | Dec 5, 2024 | Substantially Equivalent |
| K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit | Nov 1, 2024 | Substantially Equivalent |
| K241259 | Amplatz Goose Neck Snare Kit | Jun 3, 2024 | Substantially Equivalent |
| K240693 | LINQ II Insertable Cardiac Monitor (ICM) | Mar 28, 2024 | Substantially Equivalent |
| K233943 | Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) | Mar 8, 2024 | Substantially Equivalent |
| K231206 | DLP Silicone Coronary Artery Ostial Cannulae | Dec 7, 2023 | Substantially Equivalent |
| K233562 | LINQ II Insertable Cardiac Monitor | Dec 6, 2023 | Substantially Equivalent |
| K233397 | Cosine-10TM Diagnostic Catheter | Dec 2, 2023 | Substantially Equivalent |