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)

ACS SOF-T GUIDE WIREE

K-Number: K840795 · 1984-07-02

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1984-07-02
Product CodeDQT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACS SOF-T GUIDE WIREE 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 1984-07-02 under 510(k) number K840795. The device is classified under product code DQT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS SOF-T GUIDE WIREE?

ACS SOF-T GUIDE WIREE is a medical device that received FDA 510(k) clearance on 1984-07-02. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K840795.

When did ACS SOF-T GUIDE WIREE receive FDA 510(k) clearance?

ACS SOF-T GUIDE WIREE received FDA 510(k) clearance on 1984-07-02, under 510(k) number K840795.

Who is the listed applicant for ACS SOF-T GUIDE WIREE?

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 ACS SOF-T GUIDE WIREE?

The FDA product code for ACS SOF-T GUIDE WIREE is DQT.

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 Cardiovascular Systems, 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.

K012534HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATINGK000550OTW MEGALINK SDS BILIARY STENT SYSTEMK994229VERIPATH PERIPHERAL GUIDING CATHETERK992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIREK990867RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18K963702ACS HI-TORQUE IRON MAN GUIDE WIRE

View all 103 devices →

Related Devices (Code: DQT)

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.

K983927GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORTArterial Vascular Engineering, Inc.K945963THE OMNIGUIDE GUIDING CATHETER WITH BALLOONMicro Interventional Systems, Inc.K910916CATHLAB SILICONE OCCLUSION BALLOON CATHETERCathlab Corp.K910339AVD INTIMAX OCCLUSION CATHETERApplied Vascular Devices, Inc.K880860CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015Dlp, Inc.K880231MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETERIdeas For Medicine, Inc.

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.

↑