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FDA 510(k)

20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System

K-Number: K160374 · 2016-03-11

ApplicantTangent Medical Technologies, Inc.
Decision Date2016-03-11
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Tangent Medical Technologies, Inc.. It received FDA 510(k) clearance on 2016-03-11 under 510(k) number K160374. 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 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System?

20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System is a medical device that received FDA 510(k) clearance on 2016-03-11. The listed applicant is Tangent Medical Technologies, Inc.. The 510(k) number is K160374.

When did 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System receive FDA 510(k) clearance?

20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System received FDA 510(k) clearance on 2016-03-11, under 510(k) number K160374.

Who is the listed applicant for 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System?

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

What is the FDA product code for 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System?

The FDA product code for 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System is FOZ.

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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