OXY-1 System
Summary
Abiomed, Inc. received 510(k) clearance for OXY-1 System, a DTZ device. Cleared on 2023-02-23.
Details
Source
510(k) Clearance
External ID
K223161
Action Date
2023-02-23
Status
Traditional
Category
device
Product Code
DTZ
Product Description
OXY-1 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 413 device clearances issued this month. Abiomed, Inc. has received 5 total clearances in our database.
Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 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 Abiomed, Inc. have FDA actions?
Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K223161" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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