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FDA 510(k)

Solution Set for Epidural Use

K-Number: K161323 · 2016-11-30

ApplicantBaxter Healthcare Corporation
Decision Date2016-11-30
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Solution Set for Epidural Use is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2016-11-30 under 510(k) number K161323. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solution Set for Epidural Use?

Solution Set for Epidural Use is a medical device that received FDA 510(k) clearance on 2016-11-30. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K161323.

When did Solution Set for Epidural Use receive FDA 510(k) clearance?

Solution Set for Epidural Use received FDA 510(k) clearance on 2016-11-30, under 510(k) number K161323.

Who is the listed applicant for Solution Set for Epidural Use?

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

What is the FDA product code for Solution Set for Epidural Use?

The FDA product code for Solution Set for Epidural Use is FPA.

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Related Devices (Code: FPA)

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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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