TSI Transseptal Introducer
K-Number: K181031 · 2018-10-26
Decision Date2018-10-26
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
TSI Transseptal Introducer is a medical device manufactured by Pressure Products Medical Device Manufacturing, LLC. It received FDA 510(k) clearance on 2018-10-26 under approval 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. It is manufactured by Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K181031.
When was TSI Transseptal Introducer approved by the FDA?
TSI Transseptal Introducer received FDA 510(k) clearance on 2018-10-26, under approval number K181031.
What company makes TSI Transseptal Introducer?
TSI Transseptal Introducer is manufactured by Pressure Products Medical Device Manufacturing, LLC.
What is the FDA product code for TSI Transseptal Introducer?
The FDA product code for TSI Transseptal Introducer is DYB.
Other Devices by Pressure Products Medical Device Manufacturing, LLC
Related Devices (Code: DYB)
K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC
K162097InTRAkitMedtronic Vascular
K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc.
K153771TXM Guiding SheathTexasmedical Technologies, Inc.
K162184Edwards eSheath Introducer SetEdward Lifesciences
K153494HQS Introducer (Model 2064-HQS)Alseal
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.