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FDA 510(k)

OSTIAL PRO STENT POSITIONING SYSTEM

K-Number: K062192 · 2007-05-24

ApplicantOstial Solutions, LLC
Decision Date2007-05-24
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OSTIAL PRO STENT POSITIONING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ostial Solutions, LLC. It received FDA 510(k) clearance on 2007-05-24 under 510(k) number K062192. 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 OSTIAL PRO STENT POSITIONING SYSTEM?

OSTIAL PRO STENT POSITIONING SYSTEM is a medical device that received FDA 510(k) clearance on 2007-05-24. The listed applicant is Ostial Solutions, LLC. The 510(k) number is K062192.

When did OSTIAL PRO STENT POSITIONING SYSTEM receive FDA 510(k) clearance?

OSTIAL PRO STENT POSITIONING SYSTEM received FDA 510(k) clearance on 2007-05-24, under 510(k) number K062192.

Who is the listed applicant for OSTIAL PRO STENT POSITIONING SYSTEM?

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

What is the FDA product code for OSTIAL PRO STENT POSITIONING SYSTEM?

The FDA product code for OSTIAL PRO STENT POSITIONING SYSTEM 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

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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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