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FDA 510(k)

ArchFlo CT Midline

K-Number: K171483 · 2017-12-15

ApplicantMedcomp (Dba Medical Components, Inc.)
Decision Date2017-12-15
Product CodePND
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ArchFlo CT Midline is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp (Dba Medical Components, Inc.). It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K171483. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ArchFlo CT Midline?

ArchFlo CT Midline is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is Medcomp (Dba Medical Components, Inc.). The 510(k) number is K171483.

When did ArchFlo CT Midline receive FDA 510(k) clearance?

ArchFlo CT Midline received FDA 510(k) clearance on 2017-12-15, under 510(k) number K171483.

Who is the listed applicant for ArchFlo CT Midline?

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

What is the FDA product code for ArchFlo CT Midline?

The FDA product code for ArchFlo CT Midline is PND.

Other records listing Medcomp (Dba 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.

K171618Symetrex Long Term Hemodialysis CatheterK17133320G x 5/8 Pro-Lock CT Safety Infusion Set

Related Devices (Code: PND)

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.

K252402Midline CatheterTerumo Medical Products (Hangzhou) Co., Ltd.K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex IncorporatedK213203Provena(TM) Midline CatheterC.R. Bard, Inc.K210047Stiletto Extended Dwell CatheterPiper Access, LLCK192802primeMidline CathetersPfm Medical, Inc.K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL CatheterVygon USA

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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