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

FDA 510(k)

380 PIGGYBACK CONTROLLER

K-Number: K823026 · 1982-11-22

ApplicantImed Corp.
Decision Date1982-11-22
Product CodeLDR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

380 PIGGYBACK CONTROLLER is the device name listed in this FDA 510(k) record. The listed applicant is Imed Corp.. It received FDA 510(k) clearance on 1982-11-22 under 510(k) number K823026. The device is classified under product code LDR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 380 PIGGYBACK CONTROLLER?

380 PIGGYBACK CONTROLLER is a medical device that received FDA 510(k) clearance on 1982-11-22. The listed applicant is Imed Corp.. The 510(k) number is K823026.

When did 380 PIGGYBACK CONTROLLER receive FDA 510(k) clearance?

380 PIGGYBACK CONTROLLER received FDA 510(k) clearance on 1982-11-22, under 510(k) number K823026.

Who is the listed applicant for 380 PIGGYBACK CONTROLLER?

The FDA 510(k) record lists Imed Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 380 PIGGYBACK CONTROLLER?

The FDA product code for 380 PIGGYBACK CONTROLLER is LDR.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Imed Corp. as applicant

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.

K960512GEMINI PC-ITXK953896THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETSK950153VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVESK951922ADMINISTRATION SETS WITH BALL FLOATK950419THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETSK944320VENTED/NON-VENTED GEMINI ADMINISTRATION SET

View all 43 devices →

Related Devices (Code: LDR)

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.

K242693DEKA Infusion System, DEKA Administration SetDeka Research and Development CorporationK232316DEKA Infusion System, DEKA Administration SetDeka Research and DevelopmentK153760Volumetric Infusion ControllerDEKA Research & DevelopmentK963136PACER MODEL 100 INFUSION CONTROLLERHealth Watch, Inc.K971826ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500Alexander Mfg. Co.K971865ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3PAlexander Mfg. Co.

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.

↑