Device Dossier
Angioplasty catheter, balloon dilatation, coronary, basic
Device Dossier for Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon dilatation, coronary, basic, Class III,…
- GMDN category: Angioplasty catheter, balloon dilatation, coronary, basic
Intended purpose
The PTCA Balloon Dilatation Catheter is intended for dilatation of the stenotic portion (non-CTO) of coronary arteries for the purpose of improving myocardial perfusion.
Functional description
PTCA Semi-Compliant Balloon Dilatation Catheter is a rapid exchange of the catheter using a guidewire. The proximal shaft is a PTFE coated stainless steel tube which allows for proximal pushability with a smooth transition to the distal shaft which has a lubricious coating. Balloon allows for high pressure dilatation. Two radiopaque platinum markers are located within the balloon.