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FDA 510(k)

APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM

K-Number: K083607 · 2009-03-04

ApplicantCayenne Medical, Inc.
Decision Date2009-03-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM is the device name listed in this FDA 510(k) record. The listed applicant is Cayenne Medical, Inc.. It received FDA 510(k) clearance on 2009-03-04 under 510(k) number K083607. 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 APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM?

APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM is a medical device that received FDA 510(k) clearance on 2009-03-04. The listed applicant is Cayenne Medical, Inc.. The 510(k) number is K083607.

When did APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM receive FDA 510(k) clearance?

APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM received FDA 510(k) clearance on 2009-03-04, under 510(k) number K083607.

Who is the listed applicant for APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM?

The FDA 510(k) record lists Cayenne Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM?

The FDA product code for APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM 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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