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FDA 510(k)

EXTRACORPOREAL BLOOD CIRCUIT

K-Number: K982340 · 1999-04-30

ApplicantHaidylena Medical Egypt
Decision Date1999-04-30
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXTRACORPOREAL BLOOD CIRCUIT is the device name listed in this FDA 510(k) record. The listed applicant is Haidylena Medical Egypt. It received FDA 510(k) clearance on 1999-04-30 under 510(k) number K982340. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRACORPOREAL BLOOD CIRCUIT?

EXTRACORPOREAL BLOOD CIRCUIT is a medical device that received FDA 510(k) clearance on 1999-04-30. The listed applicant is Haidylena Medical Egypt. The 510(k) number is K982340.

When did EXTRACORPOREAL BLOOD CIRCUIT receive FDA 510(k) clearance?

EXTRACORPOREAL BLOOD CIRCUIT received FDA 510(k) clearance on 1999-04-30, under 510(k) number K982340.

Who is the listed applicant for EXTRACORPOREAL BLOOD CIRCUIT?

The FDA 510(k) record lists Haidylena Medical Egypt as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTRACORPOREAL BLOOD CIRCUIT?

The FDA product code for EXTRACORPOREAL BLOOD CIRCUIT is FJK.

Related Clinical Trials

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Other records listing Haidylena Medical Egypt 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.

K982337CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER

Related Devices (Code: FJK)

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.

K252423NovaLine Tubing Set for Hemodialysis (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd.K251341VITAL Tubing Sets for HemodialysisVital Healthcare Sdn. Bhd.K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.K243607Moda-flx Hemodialysis System™ Cartridge (102121-001 )Diality, Inc.K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCK210782Tablo CartridgeOutset Medical, 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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