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FDA 510(k)

BIOANCHOR WITH DISPOSABLE DRIVER

K-Number: K033804 · 2003-12-31

ApplicantLinvatec Corp.
Decision Date2003-12-31
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOANCHOR WITH DISPOSABLE DRIVER is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 2003-12-31 under 510(k) number K033804. 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 BIOANCHOR WITH DISPOSABLE DRIVER?

BIOANCHOR WITH DISPOSABLE DRIVER is a medical device that received FDA 510(k) clearance on 2003-12-31. The listed applicant is Linvatec Corp.. The 510(k) number is K033804.

When did BIOANCHOR WITH DISPOSABLE DRIVER receive FDA 510(k) clearance?

BIOANCHOR WITH DISPOSABLE DRIVER received FDA 510(k) clearance on 2003-12-31, under 510(k) number K033804.

Who is the listed applicant for BIOANCHOR WITH DISPOSABLE DRIVER?

The FDA 510(k) record lists Linvatec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOANCHOR WITH DISPOSABLE DRIVER?

The FDA product code for BIOANCHOR WITH DISPOSABLE DRIVER is HWC. This falls under the Cardiovascular category.

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Other records listing Linvatec Corp. as applicant

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Related Devices (Code: HWC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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