LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
Summary
Medtronic, Inc. received 510(k) clearance for LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application, a MXD device. Cleared on 2023-04-26.
Details
Source
510(k) Clearance
External ID
K230553
Action Date
2023-04-26
Status
Traditional
Category
device
Product Code
MXD
Product Description
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application. Product code: MXD.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Medtronic, Inc. has received 37 total clearances in our database.
Medtronic, Inc. has 83 FDA actions in our database, including 46 recalls and 37 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Medtronic, Inc. have FDA actions?
Medtronic, Inc. has 83 FDA actions in our database, including 46 recalls and 37 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K230553" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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