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FDA 510(k)

VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER

K-Number: K040492 · 2004-03-16

ApplicantBoston Scientific Corp
Decision Date2004-03-16
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2004-03-16 under 510(k) number K040492. 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 VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER?

VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER is a medical device that received FDA 510(k) clearance on 2004-03-16. The listed applicant is Boston Scientific Corp. The 510(k) number is K040492.

When did VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER receive FDA 510(k) clearance?

VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER received FDA 510(k) clearance on 2004-03-16, under 510(k) number K040492.

Who is the listed applicant for VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER?

The FDA product code for VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER is 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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