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FDA 510(k)

BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR

K-Number: K864179 · 1986-12-11

ApplicantAsh Medical Systems, Inc.
Decision Date1986-12-11
Product CodeFKT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR is the device name listed in this FDA 510(k) record. The listed applicant is Ash Medical Systems, Inc.. It received FDA 510(k) clearance on 1986-12-11 under 510(k) number K864179. The device is classified under product code FKT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR?

BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR is a medical device that received FDA 510(k) clearance on 1986-12-11. The listed applicant is Ash Medical Systems, Inc.. The 510(k) number is K864179.

When did BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR receive FDA 510(k) clearance?

BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR received FDA 510(k) clearance on 1986-12-11, under 510(k) number K864179.

Who is the listed applicant for BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR?

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

What is the FDA product code for BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR?

The FDA product code for BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR is FKT.

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 Ash Medical Systems, 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.

K874137MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CARK870270MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART.

Related Devices (Code: FKT)

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.

K1238352008 HEMODIALYSIS SORBENT SYSTEMRenal Solutions, Inc.K0933622008 HEMODIALYSIS SORBENT SYSTEMRenal Solutions, Inc.K070739ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500Renal Solutions, Inc.K060381ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100Renal Solutions, Inc.K043574ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000Renal Solutions, Inc.K031099SORB+HISORB+CARTRIDGERenal Solutions, Inc.

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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