NxStage PureFlow Solution
Summary
Nxstage Medical, Inc. received 510(k) clearance for NxStage PureFlow Solution, a KPO device. Cleared on 2024-01-18.
Details
Source
510(k) Clearance
External ID
K233213
Action Date
2024-01-18
Status
Traditional
Category
device
Product Code
KPO
Product Description
NxStage PureFlow Solution. Product code: KPO.
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. Nxstage Medical, Inc. has received 3 total clearances in our database.
Nxstage Medical, Inc. has 5 FDA actions in our database, including 2 recalls 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 Nxstage Medical, Inc. have FDA actions?
Nxstage Medical, Inc. has 5 FDA actions in our database, including 2 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K233213" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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