TSN Transseptal Needle
K-Number: K172950 · 2018-02-21
Decision Date2018-02-21
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
TSN Transseptal Needle is a medical device manufactured by Pressure Products Medical Device Manufacturing, LLC. It received FDA 510(k) clearance on 2018-02-21 under approval number K172950. 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 TSN Transseptal Needle?
TSN Transseptal Needle is a medical device that received FDA 510(k) clearance on 2018-02-21. It is manufactured by Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K172950.
When was TSN Transseptal Needle approved by the FDA?
TSN Transseptal Needle received FDA 510(k) clearance on 2018-02-21, under approval number K172950.
What company makes TSN Transseptal Needle?
TSN Transseptal Needle is manufactured by Pressure Products Medical Device Manufacturing, LLC.
What is the FDA product code for TSN Transseptal Needle?
The FDA product code for TSN Transseptal Needle 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.
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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
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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.