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FDA 510(k)

PERITONEAL DIALYSIS ADMIN. SET

K-Number: K780082 · 1978-01-24

ApplicantPhysio-Control Corp.
Decision Date1978-01-24
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERITONEAL DIALYSIS ADMIN. SET is the device name listed in this FDA 510(k) record. The listed applicant is Physio-Control Corp.. It received FDA 510(k) clearance on 1978-01-24 under 510(k) number K780082. 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 PERITONEAL DIALYSIS ADMIN. SET?

PERITONEAL DIALYSIS ADMIN. SET is a medical device that received FDA 510(k) clearance on 1978-01-24. The listed applicant is Physio-Control Corp.. The 510(k) number is K780082.

When did PERITONEAL DIALYSIS ADMIN. SET receive FDA 510(k) clearance?

PERITONEAL DIALYSIS ADMIN. SET received FDA 510(k) clearance on 1978-01-24, under 510(k) number K780082.

Who is the listed applicant for PERITONEAL DIALYSIS ADMIN. SET?

The FDA 510(k) record lists Physio-Control Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERITONEAL DIALYSIS ADMIN. SET?

The FDA product code for PERITONEAL DIALYSIS ADMIN. SET is KDJ.

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Other records listing Physio-Control Corp. 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.

K991910LIFEPAK 12 BIPHASICK990338NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEMK983393LIFEPAK 500 BIPHASICK973486LIFE PAK 12K962359LIFEPAK 300K955854LIFEPAK 500

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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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