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FDA 510(k)

PERITONEAL DIALYSIS CYCLER SET (8UNIT)

K-Number: K812772 · 1981-10-19

ApplicantDravon Medical, Inc.
Decision Date1981-10-19
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERITONEAL DIALYSIS CYCLER SET (8UNIT) is the device name listed in this FDA 510(k) record. The listed applicant is Dravon Medical, Inc.. It received FDA 510(k) clearance on 1981-10-19 under 510(k) number K812772. 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 CYCLER SET (8UNIT)?

PERITONEAL DIALYSIS CYCLER SET (8UNIT) is a medical device that received FDA 510(k) clearance on 1981-10-19. The listed applicant is Dravon Medical, Inc.. The 510(k) number is K812772.

When did PERITONEAL DIALYSIS CYCLER SET (8UNIT) receive FDA 510(k) clearance?

PERITONEAL DIALYSIS CYCLER SET (8UNIT) received FDA 510(k) clearance on 1981-10-19, under 510(k) number K812772.

Who is the listed applicant for PERITONEAL DIALYSIS CYCLER SET (8UNIT)?

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

What is the FDA product code for PERITONEAL DIALYSIS CYCLER SET (8UNIT)?

The FDA product code for PERITONEAL DIALYSIS CYCLER SET (8UNIT) is KDJ.

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Other records listing Dravon Medical, 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.

K873455S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSISK860770AM-100 I/A AMPACK832739STEDIFLO INFUSION SETK831842DRAVON T CLAMPK812771PERITONEAL DIALYSIS DRAINAGEK811851S-610 SHUNT ADAPTOR SET

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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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