Search Results

The Cordis 4F Infiniti™ Angiographic Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vascular system.

Cordis Nylex™ Angiography Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

Cordis Tempo™ Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.

The 4F Infiniti™ Angiographic Catheter is a single-use device designed to deliver radiopaque contrast medium to selected sites in the vascular system. The device combines an atraumatic tip with a braided body. It is compatible with 0.038" guidewire. The Infiniti™ 4F catheter is supplied sterile and is available in various lengths and tip configurations.

The 4F & 5F Tempo "M Angiography Catheters are single-use devices designed to deliver radiopaque contrast medium to selected sites in the vascular system. The device combines an atraumatic tip with a braided body. It is compatible with 0.038" guidewire. The Tempo™ 4F & 5F catheter is supplied sterile and is available in various lengths and tip configurations.

The 4F & 5F Nylex™ Angiography Catheters are single-use devices designed to deliver radiopaque contrast medium to selected sites in the vascular system. The device combines an atraumatic tip with a non-braided body. It is compatible with 0.035" guidewire. The Nylex "10 4F & 5F catheter is supplied sterile and is available in various lengths and tip configurations.

This document is a 510(k) premarket notification for angiographic catheters and does not describe acceptance criteria or a study proving that an AI device meets acceptance criteria. Instead, it describes how the modified devices (4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters) are substantially equivalent to their predicate devices based on design, intended use, and performance testing for biocompatibility, functional performance, and sterilization. Therefore, I cannot generate the requested table and information as it pertains to AI/algorithm performance.

The document specifies the following regarding the testing conducted for the device:

Performance Data:

• Biocompatibility Testing: Conducted on finished and sterilized Tempo 4F Angiographic Catheter in compliance with ISO 10993-1:2009/Cor 1:2010 and FDA guidance.
  • Tests included: In vitro cytotoxicity, Sensitization, Intracutaneous / irritation reactivity, Acute system toxicity, Material mediated pyrogenicity, Hemocompatibility (In vitro hemolysis, Partial thromboplastin time (PTT), Platelets and leukocyte counts, Complement activation (C3a & SC 5b-9), In vivo thrombogenicity).
• Device Functional Testing:
  • Pull force intermediate tip-to-distal tip
  • Pull force tip-to-body
• Sterilization Testing:
  • Bioburden
  • EO residuals
  • Bacterial Endotoxin

Conclusion: The design modifications were verified and validated through a series of tests ensuring that the proposed catheter meets all the required specifications and that the performance and functionality of the proposed devices are substantially equivalent to their predicate devices.

Ask a specific question about this device