Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
Summary
Medtronic received 510(k) clearance for Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System, a DTZ device. Cleared on 2021-09-16.
Details
Source
510(k) Clearance
External ID
K203111
Action Date
2021-09-16
Status
Traditional
Category
device
Product Code
DTZ
Product Description
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System. Product code: DTZ.
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 has received 9 total clearances in our database.
Medtronic has 9 FDA actions in our database, including 9 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 have FDA actions?
Medtronic has 9 FDA actions in our database, including 0 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K203111" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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