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FDA 510(k)

Provisio™ SLT IVUS™ System

K-Number: K233948 · 2024-04-23

ApplicantProvisio Medical, Inc.
Decision Date2024-04-23
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Provisio™ SLT IVUS™ System is the device name listed in this FDA 510(k) record. The listed applicant is Provisio Medical, Inc.. It received FDA 510(k) clearance on 2024-04-23 under 510(k) number K233948. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Provisio™ SLT IVUS™ System?

Provisio™ SLT IVUS™ System is a medical device that received FDA 510(k) clearance on 2024-04-23. The listed applicant is Provisio Medical, Inc.. The 510(k) number is K233948.

When did Provisio™ SLT IVUS™ System receive FDA 510(k) clearance?

Provisio™ SLT IVUS™ System received FDA 510(k) clearance on 2024-04-23, under 510(k) number K233948.

Who is the listed applicant for Provisio™ SLT IVUS™ System?

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

What is the FDA product code for Provisio™ SLT IVUS™ System?

The FDA product code for Provisio™ SLT IVUS™ System is OBJ.

Related Devices (Code: OBJ)

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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