Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Smisson-Cartledge Biomedical, LLC. It received FDA 510(k) clearance on 2022-08-12 under approval 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. It is manufactured by Smisson-Cartledge Biomedical, LLC. The 510(k) number is K202461.

When was ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System approved by the FDA?

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

What company makes 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 manufactured by Smisson-Cartledge Biomedical, LLC.

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 Clinical Trials

NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT05501873 Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System ACTIVE_NOT_RECRUITING NCT03031587 Validation of Thermometric Cardiac Imaging by MRI COMPLETED NCT06472622 Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort RECRUITING NCT07228117 GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes RECRUITING NCT07580560 Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study COMPLETED

Related Devices (Code: LGZ)

K161613Hang&Go PACRand S.R.L. K150404QiF Blood and Fluid WarmerQuality IN Flow , Ltd. K171215QiF Blood and Fluid WarmerQuality IN Flow , Ltd. K163708QiF Blood and Fluid WarmerQuality IN Flow , Ltd. K180154QiF Blood and Fluid WarmerQuality IN Flow , Ltd. K192325Quantum Blood and Fluid Warming SystemLife Warmer, Inc.

Official Source

View on FDA Database →

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

↑