ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
Summary
Smisson-Cartledge Biomedical, LLC received 510(k) clearance for ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System, a LGZ device. Cleared on 2022-08-12.
Details
Source
510(k) Clearance
External ID
K202461
Action Date
2022-08-12
Status
Traditional
Category
device
Product Code
LGZ
Product Description
ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System. Product code: LGZ.
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.
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 Smisson-Cartledge Biomedical, LLC have FDA actions?
This is the only FDA action we have on record for Smisson-Cartledge Biomedical, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K202461" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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