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FDA 510(k)

HEMOSORBA CH-500, CH-350 AND CH-180

K-Number: K885017 · 1989-03-17

ApplicantAsahi Medical Co., Ltd.
Decision Date1989-03-17
Product CodeFLD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMOSORBA CH-500, CH-350 AND CH-180 is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Medical Co., Ltd.. It received FDA 510(k) clearance on 1989-03-17 under 510(k) number K885017. 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 HEMOSORBA CH-500, CH-350 AND CH-180?

HEMOSORBA CH-500, CH-350 AND CH-180 is a medical device that received FDA 510(k) clearance on 1989-03-17. The listed applicant is Asahi Medical Co., Ltd.. The 510(k) number is K885017.

When did HEMOSORBA CH-500, CH-350 AND CH-180 receive FDA 510(k) clearance?

HEMOSORBA CH-500, CH-350 AND CH-180 received FDA 510(k) clearance on 1989-03-17, under 510(k) number K885017.

Who is the listed applicant for HEMOSORBA CH-500, CH-350 AND CH-180?

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

What is the FDA product code for HEMOSORBA CH-500, CH-350 AND CH-180?

The FDA product code for HEMOSORBA CH-500, CH-350 AND CH-180 is FLD.

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Other records listing Asahi Medical Co., Ltd. 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.

K041726HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EXK013418AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRYK001250APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)K991512ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-XK983720ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-K970650ASAHI AM-R SERIES DIALYZERS

View all 16 devices →

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.K984546BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TKHemocleanse, Inc.K971015AHCS HEMOPERFUSION SYSTEMAmerican Health Care Systems, Inc.K953751BIOLOGIC-DT SYSTEMHemocleanse, 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.

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