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FDA 510(k)

SIMPSON-ROBERT CORONARY GUIDING CATHET

K-Number: K813623 · 1982-01-22

ApplicantAdvanced Catheter Systems
Decision Date1982-01-22
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIMPSON-ROBERT CORONARY GUIDING CATHET is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Catheter Systems. It received FDA 510(k) clearance on 1982-01-22 under 510(k) number K813623. 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 SIMPSON-ROBERT CORONARY GUIDING CATHET?

SIMPSON-ROBERT CORONARY GUIDING CATHET is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is Advanced Catheter Systems. The 510(k) number is K813623.

When did SIMPSON-ROBERT CORONARY GUIDING CATHET receive FDA 510(k) clearance?

SIMPSON-ROBERT CORONARY GUIDING CATHET received FDA 510(k) clearance on 1982-01-22, under 510(k) number K813623.

Who is the listed applicant for SIMPSON-ROBERT CORONARY GUIDING CATHET?

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

What is the FDA product code for SIMPSON-ROBERT CORONARY GUIDING CATHET?

The FDA product code for SIMPSON-ROBERT CORONARY GUIDING CATHET 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 Advanced Catheter Systems 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.

K813577PRESSURE INDICATOR-REGULATORK813624ADVANCED CATHETER SYSTEMS CORONARY GUIDK813622INDEFLATORK813578HEMOSTATIC SIDE-ARM ADAPTER

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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