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FDA 510(k)

COAPT ENDOTINE CHIN 3.5 DEVICE

K-Number: K033524 · 2003-12-18

ApplicantCoapt Systems, Inc.
Decision Date2003-12-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COAPT ENDOTINE CHIN 3.5 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 2003-12-18 under 510(k) number K033524. 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 ENDOTINE CHIN 3.5 DEVICE?

COAPT ENDOTINE CHIN 3.5 DEVICE is a medical device that received FDA 510(k) clearance on 2003-12-18. The listed applicant is Coapt Systems, Inc.. The 510(k) number is K033524.

When did COAPT ENDOTINE CHIN 3.5 DEVICE receive FDA 510(k) clearance?

COAPT ENDOTINE CHIN 3.5 DEVICE received FDA 510(k) clearance on 2003-12-18, under 510(k) number K033524.

Who is the listed applicant for COAPT ENDOTINE CHIN 3.5 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 ENDOTINE CHIN 3.5 DEVICE?

The FDA product code for COAPT ENDOTINE CHIN 3.5 DEVICE is HWC. This falls under the Cardiovascular category.

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Other records listing Coapt Systems, 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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