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FDA 510(k)

MiniCap Extended Life PD Transfer Sets

K-Number: K192705 · 2019-10-25

ApplicantBaxter Healthcare
Decision Date2019-10-25
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MiniCap Extended Life PD Transfer Sets is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K192705. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiniCap Extended Life PD Transfer Sets?

MiniCap Extended Life PD Transfer Sets is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is Baxter Healthcare. The 510(k) number is K192705.

When did MiniCap Extended Life PD Transfer Sets receive FDA 510(k) clearance?

MiniCap Extended Life PD Transfer Sets received FDA 510(k) clearance on 2019-10-25, under 510(k) number K192705.

Who is the listed applicant for MiniCap Extended Life PD Transfer Sets?

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

What is the FDA product code for MiniCap Extended Life PD Transfer Sets?

The FDA product code for MiniCap Extended Life PD Transfer Sets is KDJ.

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Related Devices (Code: KDJ)

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.

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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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