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FDA 510(k)

Paclitaxel Sets

K-Number: K160007 · 2016-12-19

ApplicantBaxter Healthcare Corporation
Decision Date2016-12-19
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Paclitaxel Sets 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 2016-12-19 under 510(k) number K160007. 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 Paclitaxel Sets?

Paclitaxel Sets is a medical device that received FDA 510(k) clearance on 2016-12-19. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K160007.

When did Paclitaxel Sets receive FDA 510(k) clearance?

Paclitaxel Sets received FDA 510(k) clearance on 2016-12-19, under 510(k) number K160007.

Who is the listed applicant for Paclitaxel Sets?

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 Paclitaxel Sets?

The FDA product code for Paclitaxel Sets is 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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