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FDA 510(k)

COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197

K-Number: K023922 · 2002-12-20

ApplicantCoapt Systems, Inc.
Decision Date2002-12-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197 is the device name listed in this FDA 510(k) record. The listed applicant is Coapt Systems, Inc.. It received FDA 510(k) clearance on 2002-12-20 under 510(k) number K023922. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197?

COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197 is a medical device that received FDA 510(k) clearance on 2002-12-20. The listed applicant is Coapt Systems, Inc.. The 510(k) number is K023922.

When did COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197 receive FDA 510(k) clearance?

COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197 received FDA 510(k) clearance on 2002-12-20, under 510(k) number K023922.

Who is the listed applicant for COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197?

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

What is the FDA product code for COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197?

The FDA product code for COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197 is HWC. This falls under the Cardiovascular category.

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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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