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FDA 510(k)

BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK

K-Number: K984546 · 1999-08-13

ApplicantHemocleanse, Inc.
Decision Date1999-08-13
Product CodeFLD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK is the device name listed in this FDA 510(k) record. The listed applicant is Hemocleanse, Inc.. It received FDA 510(k) clearance on 1999-08-13 under 510(k) number K984546. The device is classified under product code FLD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK?

BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK is a medical device that received FDA 510(k) clearance on 1999-08-13. The listed applicant is Hemocleanse, Inc.. The 510(k) number is K984546.

When did BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK receive FDA 510(k) clearance?

BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK received FDA 510(k) clearance on 1999-08-13, under 510(k) number K984546.

Who is the listed applicant for BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK?

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

What is the FDA product code for BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK?

The FDA product code for BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK is FLD.

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 Hemocleanse, 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.

K993330THERMOCHEM-HT SYSTEMK992196BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)K953751BIOLOGIC-DT SYSTEMK923046BIOLOGIC DT-1000 MACHINE

Related Devices (Code: FLD)

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.

K113313MOLECULAR ADSORBENT RECIRCULATING(MARS)Gambro Renal Products, Inc.K033262MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)Gambro Renal ProductsK992196BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)Hemocleanse, Inc.K971015AHCS HEMOPERFUSION SYSTEMAmerican Health Care Systems, Inc.K953751BIOLOGIC-DT SYSTEMHemocleanse, Inc.K885017HEMOSORBA CH-500, CH-350 AND CH-180Asahi Medical Co., Ltd.

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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