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FDA 510(k)

MAHURKAR 8 FR DUAL LEMEN CATHETER

K-Number: K955002 · 1996-09-13

ApplicantQuinton, Inc.
Decision Date1996-09-13
Product CodeMPB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MAHURKAR 8 FR DUAL LEMEN CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1996-09-13 under 510(k) number K955002. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAHURKAR 8 FR DUAL LEMEN CATHETER?

MAHURKAR 8 FR DUAL LEMEN CATHETER is a medical device that received FDA 510(k) clearance on 1996-09-13. The listed applicant is Quinton, Inc.. The 510(k) number is K955002.

When did MAHURKAR 8 FR DUAL LEMEN CATHETER receive FDA 510(k) clearance?

MAHURKAR 8 FR DUAL LEMEN CATHETER received FDA 510(k) clearance on 1996-09-13, under 510(k) number K955002.

Who is the listed applicant for MAHURKAR 8 FR DUAL LEMEN CATHETER?

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

What is the FDA product code for MAHURKAR 8 FR DUAL LEMEN CATHETER?

The FDA product code for MAHURKAR 8 FR DUAL LEMEN CATHETER is MPB.

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Other records listing Quinton, Inc. as applicant

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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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