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FDA 510(k)

COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331

K-Number: K991102 · 1999-06-09

ApplicantGuidant Corp.
Decision Date1999-06-09
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corp.. It received FDA 510(k) clearance on 1999-06-09 under 510(k) number K991102. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331?

COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 is a medical device that received FDA 510(k) clearance on 1999-06-09. The listed applicant is Guidant Corp.. The 510(k) number is K991102.

When did COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 receive FDA 510(k) clearance?

COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 received FDA 510(k) clearance on 1999-06-09, under 510(k) number K991102.

Who is the listed applicant for COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331?

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 COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331?

The FDA product code for COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 is DTL.

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Related Devices (Code: DTL)

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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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