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FDA 510(k)

ACUITY BREAK-AWAY GUIDE CATHETER

K-Number: K093969 · 2010-03-05

ApplicantCardiac Pacemakers, Inc.
Decision Date2010-03-05
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACUITY BREAK-AWAY GUIDE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Pacemakers, Inc.. It received FDA 510(k) clearance on 2010-03-05 under 510(k) number K093969. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUITY BREAK-AWAY GUIDE CATHETER?

ACUITY BREAK-AWAY GUIDE CATHETER is a medical device that received FDA 510(k) clearance on 2010-03-05. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K093969.

When did ACUITY BREAK-AWAY GUIDE CATHETER receive FDA 510(k) clearance?

ACUITY BREAK-AWAY GUIDE CATHETER received FDA 510(k) clearance on 2010-03-05, under 510(k) number K093969.

Who is the listed applicant for ACUITY BREAK-AWAY GUIDE CATHETER?

The FDA 510(k) record lists Cardiac Pacemakers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUITY BREAK-AWAY GUIDE CATHETER?

The FDA product code for ACUITY BREAK-AWAY GUIDE CATHETER is DQY.

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Other records listing Cardiac Pacemakers, Inc. as applicant

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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.

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