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FDA 510(k)

Medline Quick Switch Valve with ENFit Connector

K-Number: K191759 · 2019-12-04

Decision Date2019-12-04
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Medline Quick Switch Valve with ENFit Connector is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2019-12-04 under 510(k) number K191759. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline Quick Switch Valve with ENFit Connector?

Medline Quick Switch Valve with ENFit Connector is a medical device that received FDA 510(k) clearance on 2019-12-04. The listed applicant is Medline Industries, Inc.. The 510(k) number is K191759.

When did Medline Quick Switch Valve with ENFit Connector receive FDA 510(k) clearance?

Medline Quick Switch Valve with ENFit Connector received FDA 510(k) clearance on 2019-12-04, under 510(k) number K191759.

Who is the listed applicant for Medline Quick Switch Valve with ENFit Connector?

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

What is the FDA product code for Medline Quick Switch Valve with ENFit Connector?

The FDA product code for Medline Quick Switch Valve with ENFit Connector is PIF.

Related Clinical Trials

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.

Other records listing Medline Industries, 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: PIF)

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.

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.