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FDA 510(k)

EXEL I.V. BLOOD LINE SET

K-Number: K992039 · 2000-02-10

ApplicantExelint Intl. Co.
Decision Date2000-02-10
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXEL I.V. BLOOD LINE SET is the device name listed in this FDA 510(k) record. The listed applicant is Exelint Intl. Co.. It received FDA 510(k) clearance on 2000-02-10 under 510(k) number K992039. 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 EXEL I.V. BLOOD LINE SET?

EXEL I.V. BLOOD LINE SET is a medical device that received FDA 510(k) clearance on 2000-02-10. The listed applicant is Exelint Intl. Co.. The 510(k) number is K992039.

When did EXEL I.V. BLOOD LINE SET receive FDA 510(k) clearance?

EXEL I.V. BLOOD LINE SET received FDA 510(k) clearance on 2000-02-10, under 510(k) number K992039.

Who is the listed applicant for EXEL I.V. BLOOD LINE SET?

The FDA 510(k) record lists Exelint Intl. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXEL I.V. BLOOD LINE SET?

The FDA product code for EXEL I.V. BLOOD LINE SET is FJK.

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Other records listing Exelint Intl. Co. 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.

K092172EXEL I.V. EXTENSION SETK052103EXEL SECURE TOUCH II SAFETY SYRINGEK031500EXCEL PRIMARY SOLUTION SETK011754EXEL SECURETOUCH PTP SYRINGEK020533EXEL VACULET BLOOD COLLECTION SETK022406EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET

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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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