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FDA 510(k)

Reprocessed Steerable Introducer

K-Number: K152090 · 2016-03-23

ApplicantSterilmed, Inc.
Decision Date2016-03-23
Product CodePNE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Steerable Introducer is a medical device manufactured by Sterilmed, Inc.. It received FDA 510(k) clearance on 2016-03-23 under approval number K152090. The device is classified under product code PNE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Steerable Introducer?

Reprocessed Steerable Introducer is a medical device that received FDA 510(k) clearance on 2016-03-23. It is manufactured by Sterilmed, Inc.. The 510(k) number is K152090.

When was Reprocessed Steerable Introducer approved by the FDA?

Reprocessed Steerable Introducer received FDA 510(k) clearance on 2016-03-23, under approval number K152090.

What company makes Reprocessed Steerable Introducer?

Reprocessed Steerable Introducer is manufactured by Sterilmed, Inc..

What is the FDA product code for Reprocessed Steerable Introducer?

The FDA product code for Reprocessed Steerable Introducer is PNE.

Related Clinical Trials

NCT06106594 VOLT CE Mark Study ACTIVE_NOT_RECRUITING NCT06223789 VOLT-AF IDE Clinical Study COMPLETED

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Related Devices (Code: PNE)

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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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