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)

TERUMO IMUGARD

K-Number: K790105 · 1979-05-24

ApplicantTerumo America, Inc.
Decision Date1979-05-24
Product CodeGKT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TERUMO IMUGARD is the device name listed in this FDA 510(k) record. The listed applicant is Terumo America, Inc.. It received FDA 510(k) clearance on 1979-05-24 under 510(k) number K790105. The device is classified under product code GKT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TERUMO IMUGARD?

TERUMO IMUGARD is a medical device that received FDA 510(k) clearance on 1979-05-24. The listed applicant is Terumo America, Inc.. The 510(k) number is K790105.

When did TERUMO IMUGARD receive FDA 510(k) clearance?

TERUMO IMUGARD received FDA 510(k) clearance on 1979-05-24, under 510(k) number K790105.

Who is the listed applicant for TERUMO IMUGARD?

The FDA 510(k) record lists Terumo America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TERUMO IMUGARD?

The FDA product code for TERUMO IMUGARD is GKT.

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 Terumo America, Inc. 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.

K811523PLASMA FLEXK802970TERUMO HOLLOW FIBER OXYGENATORK802122CLIRANS TH13 HOLLOW FIBER DIALYZERK802441CLIRANS TH10 HOLLOW FIBER DIALYZERK801194CLIRANS TE07 HOLLOW FIBER DIALYZERK801193CLIRANS TE15 HOLLOW FIBER DIALYZER

View all 31 devices →

Related Devices (Code: GKT)

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.

K200530AMICUS Separator SystemFresenius Kabi AGK162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,LlcK822521AUTOMATED BLOOD CELL SEPARATORCryosan, Inc.K820396AUTOMATED BLOOD CELL SEPAR. DISP. SFTWRPheragen Technology Corp.K801233CELLTRIFUGE IITravenol Laboratories, S.A.K791106STERILE, DISPOSABLE CENTRIFUGE BOWLTravenol Laboratories, S.A.

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.

↑