LogoFDA 510(k) Search
K Number
K092014
Device Name
SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
Manufacturer
ONSET MEDICAL CORPORATION
Date Cleared
2009-10-08

(94 days)

Product Code
DYB
Regulation Number
870.1340
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SoloPath™ Balloon Expandable TransFemoral Introducer is intended to be inserted percutaneously into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and /or devices introduced into the femoral iliac arteries.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "SoloPath™ Balloon Expandable TransFemoral Introducer." It states that the device is substantially equivalent to legally marketed predicate devices.

This type of document (a 510(k) clearance letter) does not include the detailed study information, acceptance criteria, or performance data that would be used to prove the device meets acceptance criteria. The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials to establish new efficacy or safety claims as would be required for a Premarket Approval (PMA).

Therefore, based solely on the provided text, I cannot extract the information required to populate the requested table and answer the questions about acceptance criteria and the study that proves the device meets them.

The document only provides:

  • Device Name: SoloPath™ Balloon Expandable TransFemoral Introducer
  • Intended Use: "The SoloPath™ Balloon Expandable TransFemoral Introducer is intended to be inserted percutaneously into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and /or devices introduced into the femoral iliac arteries."
  • Regulatory Class: Class II (Product Code: DYB)
  • FDA Clearance Date: October 8, 2009
  • 510(k) Number: K092014

To provide the requested information, you would need to consult the original 510(k) submission (K092014) which would contain the test reports and performance data submitted by Onset Medical Corporation to the FDA.

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).