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FDA 510(k)

BioFlo Midline Catheter

K-Number: K161866 · 2016-09-08

ApplicantNavilyst Medical, Inc.
Decision Date2016-09-08
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BioFlo Midline Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Navilyst Medical, Inc.. It received FDA 510(k) clearance on 2016-09-08 under 510(k) number K161866. 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 BioFlo Midline Catheter?

BioFlo Midline Catheter is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is Navilyst Medical, Inc.. The 510(k) number is K161866.

When did BioFlo Midline Catheter receive FDA 510(k) clearance?

BioFlo Midline Catheter received FDA 510(k) clearance on 2016-09-08, under 510(k) number K161866.

Who is the listed applicant for BioFlo Midline Catheter?

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

What is the FDA product code for BioFlo Midline Catheter?

The FDA product code for BioFlo Midline Catheter is FOZ.

Other records listing Navilyst Medical, 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.

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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.

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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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