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)

ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST

K-Number: K882803 · 1988-09-16

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1988-09-16
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST 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 1988-09-16 under 510(k) number K882803. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST?

ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST is a medical device that received FDA 510(k) clearance on 1988-09-16. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K882803.

When did ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST receive FDA 510(k) clearance?

ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST received FDA 510(k) clearance on 1988-09-16, under 510(k) number K882803.

Who is the listed applicant for ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST?

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 ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST?

The FDA product code for ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST is DQY.

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: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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.

↑