FDA 510(k)

ACS ANGIOTRAK(TM) SYSTEM

K-Number: K921719 · 1992-08-07

ApplicantAdvanced Cardiovascular Systems, Inc.

Decision Date1992-08-07

Product CodeMAV

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ACS ANGIOTRAK(TM) SYSTEM 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 1992-08-07 under 510(k) number K921719. The device is classified under product code MAV. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS ANGIOTRAK(TM) SYSTEM?

ACS ANGIOTRAK(TM) SYSTEM is a medical device that received FDA 510(k) clearance on 1992-08-07. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K921719.

When did ACS ANGIOTRAK(TM) SYSTEM receive FDA 510(k) clearance?

ACS ANGIOTRAK(TM) SYSTEM received FDA 510(k) clearance on 1992-08-07, under 510(k) number K921719.

Who is the listed applicant for ACS ANGIOTRAK(TM) SYSTEM?

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 ANGIOTRAK(TM) SYSTEM?

The FDA product code for ACS ANGIOTRAK(TM) SYSTEM is MAV.

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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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Related Devices (Code: MAV)

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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.