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FDA 510(k)

PRE-LOADED BIOSTINGER HORNET

K-Number: K020377 · 2002-05-06

ApplicantLinvatec Corp.
Decision Date2002-05-06
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRE-LOADED BIOSTINGER HORNET is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 2002-05-06 under 510(k) number K020377. 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 PRE-LOADED BIOSTINGER HORNET?

PRE-LOADED BIOSTINGER HORNET is a medical device that received FDA 510(k) clearance on 2002-05-06. The listed applicant is Linvatec Corp.. The 510(k) number is K020377.

When did PRE-LOADED BIOSTINGER HORNET receive FDA 510(k) clearance?

PRE-LOADED BIOSTINGER HORNET received FDA 510(k) clearance on 2002-05-06, under 510(k) number K020377.

Who is the listed applicant for PRE-LOADED BIOSTINGER HORNET?

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 PRE-LOADED BIOSTINGER HORNET?

The FDA product code for PRE-LOADED BIOSTINGER HORNET is HWC. This falls under the Cardiovascular category.

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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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