AcuNav Crystal Ultrasound Catheter
Summary
Siemens Medical Solutions USA, Inc. received 510(k) clearance for AcuNav Crystal Ultrasound Catheter, a OBJ device. Cleared on 2023-10-28.
Details
Source
510(k) Clearance
External ID
K233270
Action Date
2023-10-28
Status
Special
Category
device
Product Code
OBJ
Product Description
AcuNav Crystal Ultrasound Catheter. Product code: OBJ.
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. Siemens Medical Solutions USA, Inc. has received 104 total clearances in our database.
Siemens Medical Solutions USA, Inc. has 277 FDA actions in our database, including 173 recalls and 104 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 Siemens Medical Solutions USA, Inc. have FDA actions?
Siemens Medical Solutions USA, Inc. has 277 FDA actions in our database, including 173 recalls and 104 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K233270" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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