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FDA 510(k)

ULTRATINE TRANSBLEPH

K-Number: K060248 · 2006-06-12

ApplicantCoapt Systems, Inc.
Decision Date2006-06-12
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ULTRATINE TRANSBLEPH 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 2006-06-12 under 510(k) number K060248. 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 ULTRATINE TRANSBLEPH?

ULTRATINE TRANSBLEPH is a medical device that received FDA 510(k) clearance on 2006-06-12. The listed applicant is Coapt Systems, Inc.. The 510(k) number is K060248.

When did ULTRATINE TRANSBLEPH receive FDA 510(k) clearance?

ULTRATINE TRANSBLEPH received FDA 510(k) clearance on 2006-06-12, under 510(k) number K060248.

Who is the listed applicant for ULTRATINE TRANSBLEPH?

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 ULTRATINE TRANSBLEPH?

The FDA product code for ULTRATINE TRANSBLEPH 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.

K083783VF LIQUIGELK080956MODIFICATION TO VF GEL PLUSK071663VF GEL PLUSK060249ULTRATINE FOREHEADK060828MODIFICATION TO ENDOTINE RIBBONK051415ENDOTINE RIBBON

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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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