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FDA 510(k)

HEALIX TI ANCHOR

K-Number: K082282 · 2008-11-07

ApplicantDepuy Mitek, A Johnson & Johnson Co.
Decision Date2008-11-07
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALIX TI ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek, A Johnson & Johnson Co.. It received FDA 510(k) clearance on 2008-11-07 under 510(k) number K082282. 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 HEALIX TI ANCHOR?

HEALIX TI ANCHOR is a medical device that received FDA 510(k) clearance on 2008-11-07. The listed applicant is Depuy Mitek, A Johnson & Johnson Co.. The 510(k) number is K082282.

When did HEALIX TI ANCHOR receive FDA 510(k) clearance?

HEALIX TI ANCHOR received FDA 510(k) clearance on 2008-11-07, under 510(k) number K082282.

Who is the listed applicant for HEALIX TI ANCHOR?

The FDA 510(k) record lists Depuy Mitek, A Johnson & Johnson Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEALIX TI ANCHOR?

The FDA product code for HEALIX TI ANCHOR 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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