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)

ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK

K-Number: K884386 · 1989-01-05

ApplicantEthitek Pharmaceuticals Co.
Decision Date1989-01-05
Product CodeKRK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK is the device name listed in this FDA 510(k) record. The listed applicant is Ethitek Pharmaceuticals Co.. It received FDA 510(k) clearance on 1989-01-05 under 510(k) number K884386. The device is classified under product code KRK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK?

ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK is a medical device that received FDA 510(k) clearance on 1989-01-05. The listed applicant is Ethitek Pharmaceuticals Co.. The 510(k) number is K884386.

When did ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK receive FDA 510(k) clearance?

ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK received FDA 510(k) clearance on 1989-01-05, under 510(k) number K884386.

Who is the listed applicant for ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK?

The FDA 510(k) record lists Ethitek Pharmaceuticals Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK?

The FDA product code for ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK is KRK.

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: KRK)

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.

K950607UST-5268P-5 TRANSDUCERAloka Co., Ltd.K904674CENTRAL VENOUS PRESSURE MANOMETERMedex, Inc.K875322MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETERSchneider-Shilley (Usa)K861605SCHNEIDER-SHILEY PRESSURE MANOMETERShiley, Inc.K830910MANOMETER SET C.V.P. #S 298/299Exco, Inc.K813498MEDIFIXBurron Medical Products, 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.

↑