Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DIALYSIS DELIVERY SYS., ULTIM. MODEL II

K-Number: K770350 · 1977-03-08

ApplicantVital Systems, Inc.
Decision Date1977-03-08
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIALYSIS DELIVERY SYS., ULTIM. MODEL II is the device name listed in this FDA 510(k) record. The listed applicant is Vital Systems, Inc.. It received FDA 510(k) clearance on 1977-03-08 under 510(k) number K770350. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALYSIS DELIVERY SYS., ULTIM. MODEL II?

DIALYSIS DELIVERY SYS., ULTIM. MODEL II is a medical device that received FDA 510(k) clearance on 1977-03-08. The listed applicant is Vital Systems, Inc.. The 510(k) number is K770350.

When did DIALYSIS DELIVERY SYS., ULTIM. MODEL II receive FDA 510(k) clearance?

DIALYSIS DELIVERY SYS., ULTIM. MODEL II received FDA 510(k) clearance on 1977-03-08, under 510(k) number K770350.

Who is the listed applicant for DIALYSIS DELIVERY SYS., ULTIM. MODEL II?

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

What is the FDA product code for DIALYSIS DELIVERY SYS., ULTIM. MODEL II?

The FDA product code for DIALYSIS DELIVERY SYS., ULTIM. MODEL II is FKP.

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

Related Devices (Code: FKP)

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.

K181991NxStage Connected Health SystemNxstage Medical, Inc.K131739NXSTAGE CONNECTED HEALTH SYSTEMNxstage Medical, Inc.K130460NXSTAGE DOSING CALCULATORNxstage Medical, Inc.K040074ONEVIEW INTERFACENxstage Medical, Inc.K021060FRESENIUS ICARE MONITORING SYSTEMFresenius Medical Care North AmericaK003615STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPSEnvironmental Test Systems, Inc.

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.

↑