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FDA 510(k)

STEP-TIP CHRONIC HEMODIALYSIS CATHETER

K-Number: K040666 · 2004-05-14

ApplicantArrow International, Inc.
Decision Date2004-05-14
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STEP-TIP CHRONIC HEMODIALYSIS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Inc.. It received FDA 510(k) clearance on 2004-05-14 under 510(k) number K040666. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEP-TIP CHRONIC HEMODIALYSIS CATHETER?

STEP-TIP CHRONIC HEMODIALYSIS CATHETER is a medical device that received FDA 510(k) clearance on 2004-05-14. The listed applicant is Arrow International, Inc.. The 510(k) number is K040666.

When did STEP-TIP CHRONIC HEMODIALYSIS CATHETER receive FDA 510(k) clearance?

STEP-TIP CHRONIC HEMODIALYSIS CATHETER received FDA 510(k) clearance on 2004-05-14, under 510(k) number K040666.

Who is the listed applicant for STEP-TIP CHRONIC HEMODIALYSIS CATHETER?

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

What is the FDA product code for STEP-TIP CHRONIC HEMODIALYSIS CATHETER?

The FDA product code for STEP-TIP CHRONIC HEMODIALYSIS CATHETER is MSD.

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Related Devices (Code: MSD)

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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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