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FDA 510(k)

MODIFICATION TO VAXCEL DIALYSIS CATHETER

K-Number: K012948 · 2001-10-03

ApplicantBoston Scientific/Medi-Tech
Decision Date2001-10-03
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO VAXCEL DIALYSIS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific/Medi-Tech. It received FDA 510(k) clearance on 2001-10-03 under 510(k) number K012948. 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 MODIFICATION TO VAXCEL DIALYSIS CATHETER?

MODIFICATION TO VAXCEL DIALYSIS CATHETER is a medical device that received FDA 510(k) clearance on 2001-10-03. The listed applicant is Boston Scientific/Medi-Tech. The 510(k) number is K012948.

When did MODIFICATION TO VAXCEL DIALYSIS CATHETER receive FDA 510(k) clearance?

MODIFICATION TO VAXCEL DIALYSIS CATHETER received FDA 510(k) clearance on 2001-10-03, under 510(k) number K012948.

Who is the listed applicant for MODIFICATION TO VAXCEL DIALYSIS CATHETER?

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

What is the FDA product code for MODIFICATION TO VAXCEL DIALYSIS CATHETER?

The FDA product code for MODIFICATION TO VAXCEL DIALYSIS CATHETER is MSD.

Related Clinical Trials

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Other records listing Boston Scientific/Medi-Tech 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.

K023870FLEXIMA BILIARY CATHETERK020012MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETERK012952HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFTK011664IMAGER II ANGIOGRAPHIC CATHETER

Related Devices (Code: MSD)

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.

K241581Hemodialysis CatheterHaolang Medical USA CorporationK210461End CapMedical Components Inc (Medcomp)K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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