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FDA 510(k)

PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT

K-Number: K984022 · 1999-05-18

ApplicantArrow Intl., Inc.
Decision Date1999-05-18
Product CodeMPB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION 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 1999-05-18 under 510(k) number K984022. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT?

PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT is a medical device that received FDA 510(k) clearance on 1999-05-18. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K984022.

When did PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT receive FDA 510(k) clearance?

PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT received FDA 510(k) clearance on 1999-05-18, under 510(k) number K984022.

Who is the listed applicant for PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION 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 PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT?

The FDA product code for PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT is MPB.

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Related Devices (Code: MPB)

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.

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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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