VenaCore Thrombectomy Catheter (46-101)
Summary
Inari Medical, Inc. received 510(k) clearance for VenaCore Thrombectomy Catheter (46-101), a QEW device. Cleared on 2024-02-09.
Details
Source
510(k) Clearance
External ID
K234034
Action Date
2024-02-09
Status
Traditional
Category
device
Product Code
QEW
Product Description
VenaCore Thrombectomy Catheter (46-101). Product code: QEW.
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. Inari Medical, Inc. has received 21 total clearances in our database.
Inari Medical, Inc. has 21 FDA actions in our database, including 21 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 Inari Medical, Inc. have FDA actions?
Inari Medical, Inc. has 21 FDA actions in our database, including 0 recalls and 21 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K234034" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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