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FDA 510(k)

CENTRAL VEIN CATHERIZATION KIT

K-Number: K823758 · 1983-02-23

ApplicantAccess Devices, Inc.
Decision Date1983-02-23
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CENTRAL VEIN CATHERIZATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Access Devices, Inc.. It received FDA 510(k) clearance on 1983-02-23 under 510(k) number K823758. 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 CENTRAL VEIN CATHERIZATION KIT?

CENTRAL VEIN CATHERIZATION KIT is a medical device that received FDA 510(k) clearance on 1983-02-23. The listed applicant is Access Devices, Inc.. The 510(k) number is K823758.

When did CENTRAL VEIN CATHERIZATION KIT receive FDA 510(k) clearance?

CENTRAL VEIN CATHERIZATION KIT received FDA 510(k) clearance on 1983-02-23, under 510(k) number K823758.

Who is the listed applicant for CENTRAL VEIN CATHERIZATION KIT?

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

What is the FDA product code for CENTRAL VEIN CATHERIZATION KIT?

The FDA product code for CENTRAL VEIN CATHERIZATION KIT 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_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 Access Devices, 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.

K823017INTRAVENOUS CATHETER PLACEMENT UNIT &K822834ACCESS PERCUTANEOUS INTRODUCER SET

Related Devices (Code: DQO)

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.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal 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 VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

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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