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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 a medical device manufactured by Maquet Critical Care AB. It received FDA 510(k) clearance on 2017-03-02 under approval 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. It is manufactured by Maquet Critical Care AB. The 510(k) number is K153688.

When was Edi Catheter ENFit approved by the FDA?

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

What company makes Edi Catheter ENFit?

Edi Catheter ENFit is manufactured by Maquet Critical Care AB.

What is the FDA product code for Edi Catheter ENFit?

The FDA product code for Edi Catheter ENFit is PIF.

Other Devices by Maquet Critical Care AB

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Related Devices (Code: PIF)

K160642Medline ENFit SyringeMedline Industries, Inc. K161003EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit ConnectorBoston Scientific Corporation K151503NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBEGbuk Enteral Limited K170162Vesco Medical Nasoenteric Feeding TubesVesco Medical, LLC K170555U Deliver Bolink ENFit Enteral Feeding SetsU Deliver Medical, LLC K171347Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit ConnectionXeridiem Medical Devices

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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