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FDA 510(k)

FASTIN RC ANCHOR

K-Number: K041075 · 2004-11-09

ApplicantDepuy Mitek, A Johnson & Johnson Company
Decision Date2004-11-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FASTIN RC ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. It received FDA 510(k) clearance on 2004-11-09 under 510(k) number K041075. 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 FASTIN RC ANCHOR?

FASTIN RC ANCHOR is a medical device that received FDA 510(k) clearance on 2004-11-09. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. The 510(k) number is K041075.

When did FASTIN RC ANCHOR receive FDA 510(k) clearance?

FASTIN RC ANCHOR received FDA 510(k) clearance on 2004-11-09, under 510(k) number K041075.

Who is the listed applicant for FASTIN RC ANCHOR?

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

What is the FDA product code for FASTIN RC ANCHOR?

The FDA product code for FASTIN RC 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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