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FDA 510(k)

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)

K-Number: K241042 · 2024-05-17

ApplicantPressure Products Medical Device Manufacturing, LLC
Decision Date2024-05-17
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) is a medical device manufactured by Pressure Products Medical Device Manufacturing, LLC. It received FDA 510(k) clearance on 2024-05-17 under approval number K241042. 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 SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)?

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) is a medical device that received FDA 510(k) clearance on 2024-05-17. It is manufactured by Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K241042.

When was SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) approved by the FDA?

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) received FDA 510(k) clearance on 2024-05-17, under approval number K241042.

What company makes SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)?

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) is manufactured by Pressure Products Medical Device Manufacturing, LLC.

What is the FDA product code for SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)?

The FDA product code for SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) is DRC.

Related Clinical Trials

NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING NCT07515040 Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- Guidance RECRUITING

Other Devices by Pressure Products Medical Device Manufacturing, LLC

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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 K172934Needle Free Transseptal CannulaPressure Products Medical Device Manufacturing, LLC K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLC K221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLC

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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