(64 days)
The Rebar Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.
The Rebar Micro Catheter is a single-lumen catheter designed to be introduced over a steerable guidewire into the distal vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a semi-rigid proximal shaft which tapers into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The outer surface of the catheter has a lubricious hydrophilic coating. The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. Select catheter models (.0165" lumen) have a secondary marker 3 cm proximal of the distal tip marker.
The provided text describes the 510(k) summary for the Rebar™ Micro Catheter, which is an infusion catheter, and the FDA's clearance letter for the device. The information focuses on the device's substantial equivalence to a predicate device and its biocompatibility and performance testing against industry standards.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1, Biological Evaluation of Medical Devices (for external communicating, blood contact, short duration device ( |
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).