Multi-Link X2 ECG Cable and Leadwire System
Summary
Vyaire Medical, Inc. received 510(k) clearance for Multi-Link X2 ECG Cable and Leadwire System, a DSA device. Cleared on 2021-08-16.
Details
Source
510(k) Clearance
External ID
K211294
Action Date
2021-08-16
Status
Traditional
Category
device
Product Code
DSA
Product Description
Multi-Link X2 ECG Cable and Leadwire System. Product code: DSA.
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. Vyaire Medical, Inc. has received 3 total clearances in our database.
Vyaire Medical, Inc. has 4 FDA actions in our database, including 1 recall and 3 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 Vyaire Medical, Inc. have FDA actions?
Vyaire Medical, Inc. has 4 FDA actions in our database, including 1 recall and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K211294" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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