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FDA 510(k)

LAGWIRE SYSTEM

K-Number: K070393 · 2007-05-04

ApplicantFxdevices
Decision Date2007-05-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LAGWIRE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fxdevices. It received FDA 510(k) clearance on 2007-05-04 under 510(k) number K070393. 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 LAGWIRE SYSTEM?

LAGWIRE SYSTEM is a medical device that received FDA 510(k) clearance on 2007-05-04. The listed applicant is Fxdevices. The 510(k) number is K070393.

When did LAGWIRE SYSTEM receive FDA 510(k) clearance?

LAGWIRE SYSTEM received FDA 510(k) clearance on 2007-05-04, under 510(k) number K070393.

Who is the listed applicant for LAGWIRE SYSTEM?

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

What is the FDA product code for LAGWIRE SYSTEM?

The FDA product code for LAGWIRE SYSTEM is HWC. This falls under the Cardiovascular category.

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Other records listing Fxdevices as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K091806POGO SCREW INSTRUMENTATION TRAYK092189POGO SCREWK080649POGO SCREW

Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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