NG Delivery Catheter
Summary
Balt USA, LLC received 510(k) clearance for NG Delivery Catheter, a QJP device. Cleared on 2023-09-13.
Details
Source
510(k) Clearance
External ID
K230609
Action Date
2023-09-13
Status
Traditional
Category
device
Product Code
QJP
Product Description
NG Delivery Catheter. Product code: QJP.
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. Balt USA, LLC has received 12 total clearances in our database.
Balt USA, LLC has 20 FDA actions in our database, including 8 recalls 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 Balt USA, LLC have FDA actions?
Balt USA, LLC has 20 FDA actions in our database, including 8 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K230609" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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