| Z-0731-2025 | Class II | 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conju | November 6, 2024 |
| Z-0733-2025 | Class II | 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures. | November 6, 2024 |
| Z-0732-2025 | Class II | 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures. | November 6, 2024 |
| Z-0730-2025 | Class II | 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interve | November 6, 2024 |
| Z-0116-2023 | Class II | Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System | September 8, 2022 |
| Z-0115-2023 | Class II | Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System | September 8, 2022 |
| Z-0117-2023 | Class II | Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Cli | September 8, 2022 |
| Z-1095-2022 | Class I | Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO | March 30, 2022 |
| Z-0923-2022 | Class II | 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01) | March 11, 2022 |
| Z-0924-2022 | Class II | INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01) | March 11, 2022 |
| Z-0921-2022 | Class II | 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01) | March 11, 2022 |
| Z-0922-2022 | Class II | 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priori | March 11, 2022 |
| Z-0925-2022 | Class II | Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/. | March 11, 2022 |
| Z-2370-2020 | Class II | Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nomi | March 25, 2020 |
| Z-1132-2020 | Class I | NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC T | January 29, 2020 |
| Z-1144-2020 | Class I | NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The N | January 29, 2020 |
| Z-1129-2020 | Class I | NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC | January 29, 2020 |
| Z-1136-2020 | Class I | NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC T | January 29, 2020 |
| Z-1137-2020 | Class I | NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC The NC | January 29, 2020 |
| Z-1135-2020 | Class I | NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC The NC | January 29, 2020 |