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FDA 510(k)

ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System

K-Number: K202461 · 2022-08-12

ApplicantSmisson-Cartledge Biomedical, LLC
Decision Date2022-08-12
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Smisson-Cartledge Biomedical, LLC. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K202461. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System?

ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Smisson-Cartledge Biomedical, LLC. The 510(k) number is K202461.

When did ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System receive FDA 510(k) clearance?

ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System received FDA 510(k) clearance on 2022-08-12, under 510(k) number K202461.

Who is the listed applicant for ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System?

The FDA 510(k) record lists Smisson-Cartledge Biomedical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System?

The FDA product code for ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System is LGZ.

Related Devices (Code: LGZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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