FDA 510(k)

ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE

K-Number: K983033 · 1998-11-10

Decision Date1998-11-10

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corp.. It received FDA 510(k) clearance on 1998-11-10 under 510(k) number K983033. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE?

ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE is a medical device that received FDA 510(k) clearance on 1998-11-10. The listed applicant is Guidant Corp.. The 510(k) number is K983033.

When did ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE receive FDA 510(k) clearance?

ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE received FDA 510(k) clearance on 1998-11-10, under 510(k) number K983033.

Who is the listed applicant for ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE?

The FDA 510(k) record lists Guidant Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE?

The FDA product code for ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE is DQX.

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Other records listing Guidant Corp. as applicant

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Related Devices (Code: DQX)

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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.