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FDA 510(k)

DEXTROLYTE II PERITONEAL DIALYSIS PUMP

K-Number: K915628 · 1992-03-16

ApplicantNational Medical Care, Medical Products Div., Inc.
Decision Date1992-03-16
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEXTROLYTE II PERITONEAL DIALYSIS PUMP is the device name listed in this FDA 510(k) record. The listed applicant is National Medical Care, Medical Products Div., Inc.. It received FDA 510(k) clearance on 1992-03-16 under 510(k) number K915628. 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 DEXTROLYTE II PERITONEAL DIALYSIS PUMP?

DEXTROLYTE II PERITONEAL DIALYSIS PUMP is a medical device that received FDA 510(k) clearance on 1992-03-16. The listed applicant is National Medical Care, Medical Products Div., Inc.. The 510(k) number is K915628.

When did DEXTROLYTE II PERITONEAL DIALYSIS PUMP receive FDA 510(k) clearance?

DEXTROLYTE II PERITONEAL DIALYSIS PUMP received FDA 510(k) clearance on 1992-03-16, under 510(k) number K915628.

Who is the listed applicant for DEXTROLYTE II PERITONEAL DIALYSIS PUMP?

The FDA 510(k) record lists National Medical Care, Medical Products Div., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEXTROLYTE II PERITONEAL DIALYSIS PUMP?

The FDA product code for DEXTROLYTE II PERITONEAL DIALYSIS PUMP is KDJ.

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Other records listing National Medical Care, Medical Products Div., Inc. 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.

K962081COMBILINES HEMODIALYSIS BLOOD TUBING SETK941757FORMALIN REUSE CARTK952343FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZERK930843RAPID DISCONNECT Y-SET, CAT. NO. 48-7000K914790HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-RK920697DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP

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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.

K250404stay•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, LLCK231849MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483Baxter HealthcareK21401615L Cycler Drainage BagBaxter Healthcare CorporationK192705MiniCap Extended Life PD Transfer SetsBaxter HealthcareK173593stay•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, LLCK173651Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetFresenius Medical Care Renal Therapies Group, LLC

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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