Impress Angiographic Catheter
Summary
Merit Medical Systems, Inc. received 510(k) clearance for Impress Angiographic Catheter, a DQO device. Cleared on 2024-05-22.
Details
Source
510(k) Clearance
External ID
K233268
Action Date
2024-05-22
Status
Special
Category
device
Product Code
DQO
Product Description
Impress Angiographic Catheter. 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. Merit Medical Systems, Inc. has received 22 total clearances in our database.
Merit Medical Systems, Inc. has 117 FDA actions in our database, including 95 recalls and 22 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 Merit Medical Systems, Inc. have FDA actions?
Merit Medical Systems, Inc. has 117 FDA actions in our database, including 95 recalls and 22 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K233268" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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