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FDA 510(k)

MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN

K-Number: K991320 · 1999-11-10

ApplicantMedical Components, Inc.
Decision Date1999-11-10
Product CodeMPB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc.. It received FDA 510(k) clearance on 1999-11-10 under 510(k) number K991320. 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 MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN?

MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN is a medical device that received FDA 510(k) clearance on 1999-11-10. The listed applicant is Medical Components, Inc.. The 510(k) number is K991320.

When did MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN receive FDA 510(k) clearance?

MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN received FDA 510(k) clearance on 1999-11-10, under 510(k) number K991320.

Who is the listed applicant for MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN?

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

What is the FDA product code for MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN?

The FDA product code for MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN is MPB.

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Other records listing Medical Components, Inc. 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.

K25083614F Duo-Flow® Side X Side Double Lumen CatheterK1316876F X 60CM TRIPLE PRO-LINE CT BASIC IR SETK1306872F & 3F VASCU-SHEATH TEARAWAY INTRODUCERK1309235F DIGNITY CT TITANIUM PORTK124046VALVED TEARAWAY INTRODUCER GENERATION IIK1236173F PRO-PICC

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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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