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)

HEMODIALYSIS FISTULA SET

K-Number: K770864 · 1977-06-24

ApplicantVenospital, Inc.
Decision Date1977-06-24
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMODIALYSIS FISTULA SET is the device name listed in this FDA 510(k) record. The listed applicant is Venospital, Inc.. It received FDA 510(k) clearance on 1977-06-24 under 510(k) number K770864. The device is classified under product code FIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMODIALYSIS FISTULA SET?

HEMODIALYSIS FISTULA SET is a medical device that received FDA 510(k) clearance on 1977-06-24. The listed applicant is Venospital, Inc.. The 510(k) number is K770864.

When did HEMODIALYSIS FISTULA SET receive FDA 510(k) clearance?

HEMODIALYSIS FISTULA SET received FDA 510(k) clearance on 1977-06-24, under 510(k) number K770864.

Who is the listed applicant for HEMODIALYSIS FISTULA SET?

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

What is the FDA product code for HEMODIALYSIS FISTULA SET?

The FDA product code for HEMODIALYSIS FISTULA SET is FIE.

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 Venospital, 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.

K791131FLU VEN TR-1K791130FLU-VEN TK-2K790424FLU-VEN 01510K790077BIOSTIL # 3884K781186INFUSION, VENOTHIN 23K781189FLU VEN 0151

View all 14 devices →

Related Devices (Code: FIE)

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.

K253469Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)Mozarc Medical Us, LLCK251877JMS CAVEO A.V. Fistula Needle SetJMS North America CorporationK213015DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.K171505Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)Dimesol, Inc.K163025DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.K112734APLAN A.V. FISTULA NEEDLE SETAplan Well Enterprise Co., Ltd.

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.

↑