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FDA 510(k)

ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH

K-Number: K926421 · 1993-03-23

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1993-03-23
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH 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 1993-03-23 under 510(k) number K926421. 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 ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH?

ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH is a medical device that received FDA 510(k) clearance on 1993-03-23. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K926421.

When did ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH receive FDA 510(k) clearance?

ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH received FDA 510(k) clearance on 1993-03-23, under 510(k) number K926421.

Who is the listed applicant for ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH?

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 ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH?

The FDA product code for ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH is DQY.

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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.

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