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FDA 510(k)

TRAUMAFUSE RAPID INFUSION DEVICE

K-Number: K890077 · 1989-04-03

ApplicantThe Traumafuse Co.
Decision Date1989-04-03
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRAUMAFUSE RAPID INFUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is The Traumafuse Co.. It received FDA 510(k) clearance on 1989-04-03 under 510(k) number K890077. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAUMAFUSE RAPID INFUSION DEVICE?

TRAUMAFUSE RAPID INFUSION DEVICE is a medical device that received FDA 510(k) clearance on 1989-04-03. The listed applicant is The Traumafuse Co.. The 510(k) number is K890077.

When did TRAUMAFUSE RAPID INFUSION DEVICE receive FDA 510(k) clearance?

TRAUMAFUSE RAPID INFUSION DEVICE received FDA 510(k) clearance on 1989-04-03, under 510(k) number K890077.

Who is the listed applicant for TRAUMAFUSE RAPID INFUSION DEVICE?

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

What is the FDA product code for TRAUMAFUSE RAPID INFUSION DEVICE?

The FDA product code for TRAUMAFUSE RAPID INFUSION DEVICE is DTN.

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 The Traumafuse Co. 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.

K895162TRAUMAFUSE TRACH SHIELDK894721TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVEK895132CONNELL-STEPHENS ENDO ANESS TUBE

Related Devices (Code: DTN)

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.

K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L.K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mLMedtronic Cardiac SurgeryK223361BMR 1900 PHISIOSorin Group Italia S.R.L.K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc.K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F CSorin Group Italia S.R.L.

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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