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FDA 510(k)

BD Curve Ascites Shunt

K-Number: K170405 · 2017-11-02

ApplicantCare Fusion
Decision Date2017-11-02
Product CodeKPM
Advisory CommitteeGU
DecisionUnknown

Device Summary

BD Curve Ascites Shunt is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2017-11-02 under 510(k) number K170405. The device is classified under product code KPM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the BD Curve Ascites Shunt?

BD Curve Ascites Shunt is a medical device that received FDA 510(k) clearance on 2017-11-02. The listed applicant is Care Fusion. The 510(k) number is K170405.

When did BD Curve Ascites Shunt receive FDA 510(k) clearance?

BD Curve Ascites Shunt received FDA 510(k) clearance on 2017-11-02, under 510(k) number K170405.

Who is the listed applicant for BD Curve Ascites Shunt?

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

What is the FDA product code for BD Curve Ascites Shunt?

The FDA product code for BD Curve Ascites Shunt is KPM.

Other records listing Care Fusion 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.

K233021BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access DeviceK231888BD Texium™ Needle-Free SyringeK221327BD Alaris™ Pump Infusion SetsK221319BD Alaris™ Pump Epidural Infusion SetK223101BD Secondary Infusion SetK223088BD SmartSite™ Needle-Free Connector

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Related Devices (Code: KPM)

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.

K231096Automatic Continuous Effusion Shunt (ACES) System ACES SystemPleural Dynamics, Inc.

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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