FDA 510(k)

H-FLOW VALVE

K-Number: K034043 · 2004-06-30

Decision Date2004-06-30

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

H-FLOW VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Elcam Medical Acal. It received FDA 510(k) clearance on 2004-06-30 under 510(k) number K034043. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H-FLOW VALVE?

H-FLOW VALVE is a medical device that received FDA 510(k) clearance on 2004-06-30. The listed applicant is Elcam Medical Acal. The 510(k) number is K034043.

When did H-FLOW VALVE receive FDA 510(k) clearance?

H-FLOW VALVE received FDA 510(k) clearance on 2004-06-30, under 510(k) number K034043.

Who is the listed applicant for H-FLOW VALVE?

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

What is the FDA product code for H-FLOW VALVE?

The FDA product code for H-FLOW VALVE is DQO.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Elcam Medical Acal as applicant

K231900A-TAP (previously called Arthrotap)K211204SafePort(TM) Manifold (or Stopcock)K190489Elcam Stopcocks and Manifolds K123084DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD K120253ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)K120624ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)

View all 15 devices →

Related Devices (Code: DQO)

K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular K250751DualView CatheterTerumo Corporation K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC K242420pNOVUS 21 MicrocatheterPhenox, 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.