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)

MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS

K-Number: K855251 · 1986-02-04

ApplicantAdvocacy International, Ltd.
Decision Date1986-02-04
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS is the device name listed in this FDA 510(k) record. The listed applicant is Advocacy International, Ltd.. It received FDA 510(k) clearance on 1986-02-04 under 510(k) number K855251. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS?

MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS is a medical device that received FDA 510(k) clearance on 1986-02-04. The listed applicant is Advocacy International, Ltd.. The 510(k) number is K855251.

When did MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS receive FDA 510(k) clearance?

MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS received FDA 510(k) clearance on 1986-02-04, under 510(k) number K855251.

Who is the listed applicant for MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS?

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

What is the FDA product code for MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS?

The FDA product code for MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS is KDI.

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 Advocacy International, 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.

K874027LIPASE UV [TOYO]K873792SEPACELL R-500 AND SEPACELL R-500AK855212ASAHI AM SERIES DIALYZERSK854259SEPACELL R-500 & SEPACELL R-500AK842103TOYO JOZO URIC ACID TESTK842104TOYO JOZO G-GTP TEST

View all 13 devices →

Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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.

↑