FDA 510(k)

ACS ANGIOSCOPIC CATHETER

K-Number: K905715 · 1991-03-18

ApplicantAdvanced Cardiovascular Systems, Inc.

Decision Date1991-03-18

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ACS ANGIOSCOPIC CATHETER 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 1991-03-18 under 510(k) number K905715. 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 ACS ANGIOSCOPIC CATHETER?

ACS ANGIOSCOPIC CATHETER is a medical device that received FDA 510(k) clearance on 1991-03-18. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K905715.

When did ACS ANGIOSCOPIC CATHETER receive FDA 510(k) clearance?

ACS ANGIOSCOPIC CATHETER received FDA 510(k) clearance on 1991-03-18, under 510(k) number K905715.

Who is the listed applicant for ACS ANGIOSCOPIC CATHETER?

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 ANGIOSCOPIC CATHETER?

The FDA product code for ACS ANGIOSCOPIC CATHETER 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.