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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 a medical device manufactured by Baxter Healthcare. It received FDA 510(k) clearance on 2019-10-25 under approval 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. It is manufactured by Baxter Healthcare. The 510(k) number is K192705.

When was MiniCap Extended Life PD Transfer Sets approved by the FDA?

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

What company makes MiniCap Extended Life PD Transfer Sets?

MiniCap Extended Life PD Transfer Sets is manufactured by Baxter Healthcare.

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.

Other Devices by Baxter Healthcare

K231849MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483

Related Devices (Code: KDJ)

K151620Firefly Peritoneal Dialysis Connector Disinfection SystemPuracath Medical, Inc. K173593stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inchFresenius Medical Care Renal Therapies Group, LLC K173651Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetFresenius Medical Care Renal Therapies Group, LLC K173363Cycler Drain Bag SetFresenius Medical Care Renal Therapies Group, LLC K21401615L Cycler Drainage BagBaxter Healthcare Corporation K231849MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483Baxter Healthcare

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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