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FDA 510(k)

HEMOCONCENTRATOR KIT

K-Number: K850979 · 1985-07-29

ApplicantOmnis Surgical, Inc.
Decision Date1985-07-29
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMOCONCENTRATOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Omnis Surgical, Inc.. It received FDA 510(k) clearance on 1985-07-29 under 510(k) number K850979. 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 HEMOCONCENTRATOR KIT?

HEMOCONCENTRATOR KIT is a medical device that received FDA 510(k) clearance on 1985-07-29. The listed applicant is Omnis Surgical, Inc.. The 510(k) number is K850979.

When did HEMOCONCENTRATOR KIT receive FDA 510(k) clearance?

HEMOCONCENTRATOR KIT received FDA 510(k) clearance on 1985-07-29, under 510(k) number K850979.

Who is the listed applicant for HEMOCONCENTRATOR KIT?

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

What is the FDA product code for HEMOCONCENTRATOR KIT?

The FDA product code for HEMOCONCENTRATOR KIT 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 Omnis Surgical, 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.

K854518EPIDURAL ANESTHESIA TRAYK844993COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720K843595CARDIOTOMY RESERVOIR W/FILTER

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

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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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