Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
Summary
Qura S.R.L received 510(k) clearance for Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor, a KFM device. Cleared on 2021-11-03.
Details
Source
510(k) Clearance
External ID
K201320
Action Date
2021-11-03
Status
Traditional
Category
device
Product Code
KFM
Product Description
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor. Product code: KFM.
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. Qura S.R.L has received 12 total clearances in our database.
Qura S.R.L has 13 FDA actions in our database, including 1 recall and 12 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 Qura S.R.L have FDA actions?
Qura S.R.L has 13 FDA actions in our database, including 1 recall and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K201320" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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