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FDA 510(k)

TSI Transseptal Introducer

K-Number: K181031 · 2018-10-26

ApplicantPressure Products Medical Device Manufacturing, LLC
Decision Date2018-10-26
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TSI Transseptal Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. It received FDA 510(k) clearance on 2018-10-26 under 510(k) number K181031. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TSI Transseptal Introducer?

TSI Transseptal Introducer is a medical device that received FDA 510(k) clearance on 2018-10-26. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K181031.

When did TSI Transseptal Introducer receive FDA 510(k) clearance?

TSI Transseptal Introducer received FDA 510(k) clearance on 2018-10-26, under 510(k) number K181031.

Who is the listed applicant for TSI Transseptal Introducer?

The FDA 510(k) record lists Pressure Products Medical Device Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSI Transseptal Introducer?

The FDA product code for TSI Transseptal Introducer is DYB.

Other records listing Pressure Products Medical Device Manufacturing, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)K221707SafeSept® Transseptal Guidewire (SS-140)K210328SafeSept Blunt NeedleK172950TSN Transseptal NeedleK172934Needle Free Transseptal Cannula

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Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, 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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