FDA 510(k)

ADVANCED CARDIOVASCULAR-CORONARY GUID

K-Number: K842195 · 1984-07-13

ApplicantAdvanced Cardiovascular Systems, Inc.

Decision Date1984-07-13

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ADVANCED CARDIOVASCULAR-CORONARY GUID 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 1984-07-13 under 510(k) number K842195. 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 ADVANCED CARDIOVASCULAR-CORONARY GUID?

ADVANCED CARDIOVASCULAR-CORONARY GUID is a medical device that received FDA 510(k) clearance on 1984-07-13. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K842195.

When did ADVANCED CARDIOVASCULAR-CORONARY GUID receive FDA 510(k) clearance?

ADVANCED CARDIOVASCULAR-CORONARY GUID received FDA 510(k) clearance on 1984-07-13, under 510(k) number K842195.

Who is the listed applicant for ADVANCED CARDIOVASCULAR-CORONARY GUID?

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 ADVANCED CARDIOVASCULAR-CORONARY GUID?

The FDA product code for ADVANCED CARDIOVASCULAR-CORONARY GUID is DQO.

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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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.