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FDA 510(k)

Needle Free Transseptal Cannula

K-Number: K172934 · 2018-02-16

ApplicantPressure Products Medical Device Manufacturing, LLC
Decision Date2018-02-16
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Needle Free Transseptal Cannula is a medical device manufactured by Pressure Products Medical Device Manufacturing, LLC. It received FDA 510(k) clearance on 2018-02-16 under approval number K172934. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Needle Free Transseptal Cannula?

Needle Free Transseptal Cannula is a medical device that received FDA 510(k) clearance on 2018-02-16. It is manufactured by Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K172934.

When was Needle Free Transseptal Cannula approved by the FDA?

Needle Free Transseptal Cannula received FDA 510(k) clearance on 2018-02-16, under approval number K172934.

What company makes Needle Free Transseptal Cannula?

Needle Free Transseptal Cannula is manufactured by Pressure Products Medical Device Manufacturing, LLC.

What is the FDA product code for Needle Free Transseptal Cannula?

The FDA product code for Needle Free Transseptal Cannula is DRC.

Related Clinical Trials

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Other Devices by Pressure Products Medical Device Manufacturing, LLC

K172893SafeSept Needle Free Transseptal Guidewire K170671SafeSept Transseptal Guidewire K181031TSI Transseptal Introducer K172950TSN Transseptal Needle K210328SafeSept Blunt Needle K221707SafeSept® Transseptal Guidewire (SS-140)

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Related Devices (Code: DRC)

K172893SafeSept Needle Free Transseptal GuidewirePressure Products Medical Device Manufacturing, LLC K170671SafeSept Transseptal GuidewirePressure Products Medical Device Manufacturing, LLC K172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLC K221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLC K212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.

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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