Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SafeCross Transseptal Puncture and Introducer (TSP/I) System

K-Number: K203459 · 2021-07-06

ApplicantEast End Medical I, LLC
Decision Date2021-07-06
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SafeCross Transseptal Puncture and Introducer (TSP/I) System is a medical device manufactured by East End Medical I, LLC. It received FDA 510(k) clearance on 2021-07-06 under approval number K203459. 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 SafeCross Transseptal Puncture and Introducer (TSP/I) System?

SafeCross Transseptal Puncture and Introducer (TSP/I) System is a medical device that received FDA 510(k) clearance on 2021-07-06. It is manufactured by East End Medical I, LLC. The 510(k) number is K203459.

When was SafeCross Transseptal Puncture and Introducer (TSP/I) System approved by the FDA?

SafeCross Transseptal Puncture and Introducer (TSP/I) System received FDA 510(k) clearance on 2021-07-06, under approval number K203459.

What company makes SafeCross Transseptal Puncture and Introducer (TSP/I) System?

SafeCross Transseptal Puncture and Introducer (TSP/I) System is manufactured by East End Medical I, LLC.

What is the FDA product code for SafeCross Transseptal Puncture and Introducer (TSP/I) System?

The FDA product code for SafeCross Transseptal Puncture and Introducer (TSP/I) System is DYB.

Related Clinical Trials

NCT06106594 VOLT CE Mark Study ACTIVE_NOT_RECRUITING NCT06223789 VOLT-AF IDE Clinical Study COMPLETED NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING 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 NCT06816979 Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell Lung Cancer NOT_YET_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 East End Medical I, LLC

K240600SafeCross Vascular Introducer System (4001)

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.

↑