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FDA 510(k)

OSTIAL PRO STENT POSITIONING SYSTEM

K-Number: K122089 · 2012-09-21

ApplicantMerit Medical Systems, Inc.
Decision Date2012-09-21
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 Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2012-09-21 under 510(k) number K122089. 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 2012-09-21. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K122089.

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

OSTIAL PRO STENT POSITIONING SYSTEM received FDA 510(k) clearance on 2012-09-21, under 510(k) number K122089.

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

The FDA 510(k) record lists Merit Medical Systems, Inc. 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)

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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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