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FDA 510(k)

BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR

K-Number: K983559 · 1998-12-24

ApplicantIcu Medical, Inc.
Decision Date1998-12-24
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 1998-12-24 under 510(k) number K983559. 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 BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR?

BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR is a medical device that received FDA 510(k) clearance on 1998-12-24. The listed applicant is Icu Medical, Inc.. The 510(k) number is K983559.

When did BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR receive FDA 510(k) clearance?

BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR received FDA 510(k) clearance on 1998-12-24, under 510(k) number K983559.

Who is the listed applicant for BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR?

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

What is the FDA product code for BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR?

The FDA product code for BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR is FJK.

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Other records listing Icu Medical, Inc. as applicant

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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

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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