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FDA 510(k)

MedSource CathMED IV Catheter

K-Number: K193278 · 2020-08-07

ApplicantMedsource Labs
Decision Date2020-08-07
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MedSource CathMED IV Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medsource Labs. It received FDA 510(k) clearance on 2020-08-07 under 510(k) number K193278. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MedSource CathMED IV Catheter?

MedSource CathMED IV Catheter is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is Medsource Labs. The 510(k) number is K193278.

When did MedSource CathMED IV Catheter receive FDA 510(k) clearance?

MedSource CathMED IV Catheter received FDA 510(k) clearance on 2020-08-07, under 510(k) number K193278.

Who is the listed applicant for MedSource CathMED IV Catheter?

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

What is the FDA product code for MedSource CathMED IV Catheter?

The FDA product code for MedSource CathMED IV Catheter is FOZ.

Other records listing Medsource Labs 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.

K261041ClearSafe Closed SystemK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter

Related Devices (Code: FOZ)

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.

K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)Poly Medicure Limited

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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