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FDA 510(k)

RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568

K-Number: K031903 · 2004-03-03

ApplicantGuidant Corporation
Decision Date2004-03-03
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568 is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corporation. It received FDA 510(k) clearance on 2004-03-03 under 510(k) number K031903. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568?

RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568 is a medical device that received FDA 510(k) clearance on 2004-03-03. The listed applicant is Guidant Corporation. The 510(k) number is K031903.

When did RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568 receive FDA 510(k) clearance?

RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568 received FDA 510(k) clearance on 2004-03-03, under 510(k) number K031903.

Who is the listed applicant for RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568?

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

What is the FDA product code for RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568?

The FDA product code for RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568 is DTZ.

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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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