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FDA 510(k)

BD Univia RightFit Enteral Extension Sets and Transitional Adapters

K-Number: K200082 · 2020-07-30

ApplicantMps Medical, Inc.
Decision Date2020-07-30
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BD Univia RightFit Enteral Extension Sets and Transitional Adapters is the device name listed in this FDA 510(k) record. The listed applicant is Mps Medical, Inc.. It received FDA 510(k) clearance on 2020-07-30 under 510(k) number K200082. 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 BD Univia RightFit Enteral Extension Sets and Transitional Adapters?

BD Univia RightFit Enteral Extension Sets and Transitional Adapters is a medical device that received FDA 510(k) clearance on 2020-07-30. The listed applicant is Mps Medical, Inc.. The 510(k) number is K200082.

When did BD Univia RightFit Enteral Extension Sets and Transitional Adapters receive FDA 510(k) clearance?

BD Univia RightFit Enteral Extension Sets and Transitional Adapters received FDA 510(k) clearance on 2020-07-30, under 510(k) number K200082.

Who is the listed applicant for BD Univia RightFit Enteral Extension Sets and Transitional Adapters?

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

What is the FDA product code for BD Univia RightFit Enteral Extension Sets and Transitional Adapters?

The FDA product code for BD Univia RightFit Enteral Extension Sets and Transitional Adapters is PIF.

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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