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FDA 510(k)

COAPT SYSTMES ENDOTINE DEVICE

K-Number: K014153 · 2002-03-15

ApplicantCoapt Systems, Inc.
Decision Date2002-03-15
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COAPT SYSTMES ENDOTINE DEVICE 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 2002-03-15 under 510(k) number K014153. 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 SYSTMES ENDOTINE DEVICE?

COAPT SYSTMES ENDOTINE DEVICE is a medical device that received FDA 510(k) clearance on 2002-03-15. The listed applicant is Coapt Systems, Inc.. The 510(k) number is K014153.

When did COAPT SYSTMES ENDOTINE DEVICE receive FDA 510(k) clearance?

COAPT SYSTMES ENDOTINE DEVICE received FDA 510(k) clearance on 2002-03-15, under 510(k) number K014153.

Who is the listed applicant for COAPT SYSTMES ENDOTINE DEVICE?

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 SYSTMES ENDOTINE DEVICE?

The FDA product code for COAPT SYSTMES ENDOTINE DEVICE is HWC. This falls under the Cardiovascular category.

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Other records listing Coapt Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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