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FDA 510(k)

PRE-FORMED GUIDEWIRES

K-Number: K130798 · 2013-08-23

ApplicantLake Region Medical, Inc.
Decision Date2013-08-23
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRE-FORMED GUIDEWIRES is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Medical, Inc.. It received FDA 510(k) clearance on 2013-08-23 under 510(k) number K130798. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-FORMED GUIDEWIRES?

PRE-FORMED GUIDEWIRES is a medical device that received FDA 510(k) clearance on 2013-08-23. The listed applicant is Lake Region Medical, Inc.. The 510(k) number is K130798.

When did PRE-FORMED GUIDEWIRES receive FDA 510(k) clearance?

PRE-FORMED GUIDEWIRES received FDA 510(k) clearance on 2013-08-23, under 510(k) number K130798.

Who is the listed applicant for PRE-FORMED GUIDEWIRES?

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

What is the FDA product code for PRE-FORMED GUIDEWIRES?

The FDA product code for PRE-FORMED GUIDEWIRES is DQX.

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Related Devices (Code: DQX)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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