21 CFR 870.1254 — Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1254
Identification
The ShortCut is a single-use, transfemoral percutaneous catheter system designed to split bioprosthetic aortic valve leaflets prior to transcatheter aortic valve replacement (TAVR). It is indicated for use in patients at risk of coronary ostium obstruction to facilitate valve-in-valve procedures. The device consists of a distal unit (with a splitting element and positioning arm), a delivery system, and a handle.
Classification Rationale
Class II (special controls). The device is classified as Class II because it is a percutaneous catheter for cutting or splitting heart valve leaflets, and the identified risks to health can be mitigated by general controls and the specified special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| SCZ | Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures | 2 | 1 | |
| SGO | Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures | 2 | 1 |
Special Controls
SCZ — Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
In combination with the general controls of the FD&C Act, the percutaneous catheter for cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures is subject to the following special controls:
De Novo Order DEN240017
