Zoom 6F Insert Catheters
Summary
Imperative Care, Inc. received 510(k) clearance for Zoom 6F Insert Catheters, a DQO device. Cleared on 2024-04-02.
Details
Source
510(k) Clearance
External ID
K233975
Action Date
2024-04-02
Status
Traditional
Category
device
Product Code
DQO
Product Description
Zoom 6F Insert Catheters. Product code: DQO.
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. Imperative Care, Inc. has received 11 total clearances in our database.
Imperative Care, Inc. has 12 FDA actions in our database, including 1 recall and 11 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 Imperative Care, Inc. have FDA actions?
Imperative Care, Inc. has 12 FDA actions in our database, including 1 recall and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K233975" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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