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FDA 510(k)

D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW

K-Number: K063355 · 2007-07-27

ApplicantNovosci Corp.
Decision Date2007-07-27
Product CodeMPB
Advisory CommitteeGU
DecisionUnknown

Device Summary

D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW is the device name listed in this FDA 510(k) record. The listed applicant is Novosci Corp.. It received FDA 510(k) clearance on 2007-07-27 under 510(k) number K063355. 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 D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW?

D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW is a medical device that received FDA 510(k) clearance on 2007-07-27. The listed applicant is Novosci Corp.. The 510(k) number is K063355.

When did D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW receive FDA 510(k) clearance?

D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW received FDA 510(k) clearance on 2007-07-27, under 510(k) number K063355.

Who is the listed applicant for D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW?

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

What is the FDA product code for D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW?

The FDA product code for D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW is MPB.

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Other records listing Novosci Corp. 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.

K033270NOVOSCI READY SYSTEM, MODEL RS-200K033328NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT

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

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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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