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FDA 510(k)

GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A

K-Number: K040301 · 2004-11-01

ApplicantGambro Renal Products
Decision Date2004-11-01
Product CodeMPB
Advisory CommitteeGU
DecisionUnknown

Device Summary

GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A is the device name listed in this FDA 510(k) record. The listed applicant is Gambro Renal Products. It received FDA 510(k) clearance on 2004-11-01 under 510(k) number K040301. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A?

GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A is a medical device that received FDA 510(k) clearance on 2004-11-01. The listed applicant is Gambro Renal Products. The 510(k) number is K040301.

When did GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A receive FDA 510(k) clearance?

GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A received FDA 510(k) clearance on 2004-11-01, under 510(k) number K040301.

Who is the listed applicant for GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A?

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

What is the FDA product code for GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A?

The FDA product code for GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A is MPB.

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Other records listing Gambro Renal Products 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.

K120333PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPYK072908PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPYK070414GAMBRO CARTRIDGE BLOOD SETSK063290GAMBRO QUICKSET BLOODLINESK062090PRISMA SYSTEM R03.10AK060195GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE

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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.

K25083614F Duo-Flow® Side X Side Double Lumen CatheterMedical Components, Inc.K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International CorporationK192807Duo-Flow Side x Side Double Lumen CatheterMedical Components, Inc. (dba MedComp)K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterCovidien, LLCK163458Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook Incorporated

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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