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FDA 510(k)

DIALYIS START CARE KIT

K-Number: K802361 · 1981-01-16

ApplicantMed-Pak Corp.
Decision Date1981-01-16
Product CodeFKG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIALYIS START CARE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Med-Pak Corp.. It received FDA 510(k) clearance on 1981-01-16 under 510(k) number K802361. The device is classified under product code FKG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALYIS START CARE KIT?

DIALYIS START CARE KIT is a medical device that received FDA 510(k) clearance on 1981-01-16. The listed applicant is Med-Pak Corp.. The 510(k) number is K802361.

When did DIALYIS START CARE KIT receive FDA 510(k) clearance?

DIALYIS START CARE KIT received FDA 510(k) clearance on 1981-01-16, under 510(k) number K802361.

Who is the listed applicant for DIALYIS START CARE KIT?

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

What is the FDA product code for DIALYIS START CARE KIT?

The FDA product code for DIALYIS START CARE KIT is FKG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Med-Pak 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.

K884425GLOVE, SURGICAL

Related Devices (Code: FKG)

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.

K925469JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KITJ.J. Skinner, Inc.K871630KITS AND TRAYS FOR DIALYSIS USEDove Medical SuppliesK833780CAPD PREP KITProfessional Dialysis ProductsK792207PERIDIAL PERITONEAL DIALYSIS TRAYCutter Laboratories, Inc.K790353ACUTE RENAL DIALYSIS TRAYArgon Medical Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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