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FDA 510(k)

ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE

K-Number: K042796 · 2004-11-05

ApplicantCoapt Systems, Inc.
Decision Date2004-11-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENDOTINE TRANSBLEPH 3.0/3.5 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 2004-11-05 under 510(k) number K042796. 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 ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE?

ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE is a medical device that received FDA 510(k) clearance on 2004-11-05. The listed applicant is Coapt Systems, Inc.. The 510(k) number is K042796.

When did ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE receive FDA 510(k) clearance?

ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE received FDA 510(k) clearance on 2004-11-05, under 510(k) number K042796.

Who is the listed applicant for ENDOTINE TRANSBLEPH 3.0/3.5 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 ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE?

The FDA product code for ENDOTINE TRANSBLEPH 3.0/3.5 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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