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FDA 510(k)

NuCath Wedge Pressure Catheter

K-Number: K213666 · 2022-10-06

ApplicantPfm Medical, Inc.
Decision Date2022-10-06
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NuCath Wedge Pressure Catheter is a medical device manufactured by Pfm Medical, Inc.. It received FDA 510(k) clearance on 2022-10-06 under approval number K213666. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuCath Wedge Pressure Catheter?

NuCath Wedge Pressure Catheter is a medical device that received FDA 510(k) clearance on 2022-10-06. It is manufactured by Pfm Medical, Inc.. The 510(k) number is K213666.

When was NuCath Wedge Pressure Catheter approved by the FDA?

NuCath Wedge Pressure Catheter received FDA 510(k) clearance on 2022-10-06, under approval number K213666.

What company makes NuCath Wedge Pressure Catheter?

NuCath Wedge Pressure Catheter is manufactured by Pfm Medical, Inc..

What is the FDA product code for NuCath Wedge Pressure Catheter?

The FDA product code for NuCath Wedge Pressure Catheter is DQO.

Related Clinical Trials

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Related Devices (Code: DQO)

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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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