LogoFDA 510(k) Search
K Number
K161451
Device Name
BIB Stent Placement Catheter
Manufacturer
NUMED, INC.
Date Cleared
2016-09-22

(119 days)

Product Code
NVM
Regulation Number
870.1250
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for the NuMED, Inc. BIB Stent Placement Catheter. It indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed, but does not include performance data or details of a study.

The sections you've highlighted regarding "Indications for Use" and what appears to be garbled text or non-English characters do not provide the requested information. Therefore, I cannot complete the table or answer the specific questions about acceptance criteria or a study based on the provided input.

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).