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FDA 510(k)

Edi Catheter ENFit

K-Number: K153688 · 2017-03-02

ApplicantMaquet Critical Care AB
Decision Date2017-03-02
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Edi Catheter ENFit is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Critical Care AB. It received FDA 510(k) clearance on 2017-03-02 under 510(k) number K153688. 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 Edi Catheter ENFit?

Edi Catheter ENFit is a medical device that received FDA 510(k) clearance on 2017-03-02. The listed applicant is Maquet Critical Care AB. The 510(k) number is K153688.

When did Edi Catheter ENFit receive FDA 510(k) clearance?

Edi Catheter ENFit received FDA 510(k) clearance on 2017-03-02, under 510(k) number K153688.

Who is the listed applicant for Edi Catheter ENFit?

The FDA 510(k) record lists Maquet Critical Care AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Edi Catheter ENFit?

The FDA product code for Edi Catheter ENFit is PIF.

Related Clinical Trials

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NCT06114992Servo-n HFOV Study: Safety and Performance in Neonates and InfantsCOMPLETED

Other records listing Maquet Critical Care AB as applicant

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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.

K254170Percutaneous Endoscopic Gastrostomy (PEG) KitDegania Silicone , Ltd.K242917Enteral Drainage System, Enteral Medicine strawHMC Premedical S.p.A.K250481Extension Feeding Set with ENFit™ ConnectorsSKY Medical, a.s.K240052Disposable Enteral Feeding SetsBeijing L&Z Medical Technology Development Co., Ltd.K233034Mobility+ Enteral Feeding System OTCRockfield MedicalK230326ENFit to ENFit Extension SetsVesco Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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