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FDA 510(k)

MODIFICATION TO ACS CORONARY GUIDING

K-Number: K841992 · 1984-06-11

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1984-06-11
Product CodeDAO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ACS CORONARY GUIDING 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 1984-06-11 under 510(k) number K841992. The device is classified under product code DAO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ACS CORONARY GUIDING?

MODIFICATION TO ACS CORONARY GUIDING is a medical device that received FDA 510(k) clearance on 1984-06-11. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K841992.

When did MODIFICATION TO ACS CORONARY GUIDING receive FDA 510(k) clearance?

MODIFICATION TO ACS CORONARY GUIDING received FDA 510(k) clearance on 1984-06-11, under 510(k) number K841992.

Who is the listed applicant for MODIFICATION TO ACS CORONARY GUIDING?

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 MODIFICATION TO ACS CORONARY GUIDING?

The FDA product code for MODIFICATION TO ACS CORONARY GUIDING is DAO.

Related Clinical Trials

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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: DAO)

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.

K040431ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2Roche Diagnostics Corp.K982639SPIFE URINE IFEHelena LaboratoriesK955908BOEHRINGER MANNHEIM IGM ASSAYBoehringer Mannheim Corp.K850586SPQ TEST SYSTEM FOR IMMUNOGLOBULIN MApplications LabK812487IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGMDako Corp.K800450GEMENI IGM ASSAYElectro-Nucleonics Laboratories, 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.

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