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FDA 510(k)

15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER

K-Number: K040328 · 2004-11-24

ApplicantMedcomp
Decision Date2004-11-24
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp. It received FDA 510(k) clearance on 2004-11-24 under 510(k) number K040328. 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 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER?

15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER is a medical device that received FDA 510(k) clearance on 2004-11-24. The listed applicant is Medcomp. The 510(k) number is K040328.

When did 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER receive FDA 510(k) clearance?

15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER received FDA 510(k) clearance on 2004-11-24, under 510(k) number K040328.

Who is the listed applicant for 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER?

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

What is the FDA product code for 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER?

The FDA product code for 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER is MSD.

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Other records listing Medcomp 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.

K123292T3K1029662.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICCK091954MICRO-STICK SETK091953PRO-PICCK092347PRO-PICC CTK090394VALVED TEARWAY INTRODUCER

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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

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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