FDA 510(k)

BRACHIAL CORONARY GUIDING CATHETER

K-Number: K822862 · 1982-10-18

ApplicantAdvanced Cardiovascular Systems, Inc.

Decision Date1982-10-18

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BRACHIAL CORONARY GUIDING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 1982-10-18 under 510(k) number K822862. 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 BRACHIAL CORONARY GUIDING CATHETER?

BRACHIAL CORONARY GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 1982-10-18. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K822862.

When did BRACHIAL CORONARY GUIDING CATHETER receive FDA 510(k) clearance?

BRACHIAL CORONARY GUIDING CATHETER received FDA 510(k) clearance on 1982-10-18, under 510(k) number K822862.

Who is the listed applicant for BRACHIAL CORONARY GUIDING CATHETER?

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

What is the FDA product code for BRACHIAL CORONARY GUIDING CATHETER?

The FDA product code for BRACHIAL CORONARY GUIDING CATHETER 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 Advanced Cardiovascular Systems, Inc. as applicant

K012534HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING K000550OTW MEGALINK SDS BILIARY STENT SYSTEM K994229VERIPATH PERIPHERAL GUIDING CATHETER K992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE K990867RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18 K963702ACS HI-TORQUE IRON MAN GUIDE WIRE

View all 103 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.