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FDA 510(k)

ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT

K-Number: K895417 · 1990-01-03

ApplicantArrow Intl., Inc.
Decision Date1990-01-03
Product CodeLFJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 1990-01-03 under 510(k) number K895417. The device is classified under product code LFJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT?

ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT is a medical device that received FDA 510(k) clearance on 1990-01-03. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K895417.

When did ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT receive FDA 510(k) clearance?

ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT received FDA 510(k) clearance on 1990-01-03, under 510(k) number K895417.

Who is the listed applicant for ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT?

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

What is the FDA product code for ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT?

The FDA product code for ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT is LFJ.

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Other records listing Arrow Intl., Inc. as applicant

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Related Devices (Code: LFJ)

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.

K920780MEDSURG INSERTION TRAYMedsurg Industries, Inc.K925819AKCESS0CATH KITAkcess Medical Products, Inc.K925818AKCESS-CATHAkcess Medical Products, Inc.K913468ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAYCook, Inc.K931120COAXIAL ACUTE CATHETERAkcess Medical Products, Inc.K920634SPLITTABLE SHEATH INTRODUCER SETAkcess Medical Products, 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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