AC3 Series IABP
Summary
Arrow International, LLC received 510(k) clearance for AC3 Series IABP, a DSP device. Cleared on 2023-08-30.
Details
Source
510(k) Clearance
External ID
K232343
Action Date
2023-08-30
Status
Special
Category
device
Product Code
DSP
Product Description
AC3 Series IABP. Product code: DSP.
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 413 device clearances issued this month. Arrow International, LLC has received 3 total clearances in our database.
Arrow International, LLC has 50 FDA actions in our database, including 47 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 Arrow International, LLC have FDA actions?
Arrow International, LLC has 50 FDA actions in our database, including 47 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K232343" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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