| DIAMONDBACK 360™ Coronary Orbital Atherectomy System | 10850000491417 | Class III | |
| OAS Pump | 10850000491059 | Class IIb | |
| OAS Pump | 10850000491394 | Class IIb | |
| OAS Pump | 10850000491400 | Class IIb | |
| STEALTH 360TM Peripheral Orbital Atherectomy System | 10850000491479 | Class IIa | |
| STEALTH 360™ Peripheral Orbital Atherectomy System | 10850000491448 | Class IIa | |
| STEALTH 360™ Peripheral Orbital Atherectomy System | 10850000491455 | Class IIa | |
| STEALTH 360™ Peripheral Orbital Atherectomy System | 10850000491462 | Class IIa | |
| STEALTH 360™ Peripheral Orbital Atherectomy System | 10850000491516 | Class IIa | |
| STEALTH 360™ Peripheral Orbital Atherectomy System | 10850000491523 | Class IIa | |
| VIPERSLIDE™ Lubricant | 10852528005121 | Class IIa | |
| VIPERWIRE Advance™ Coronary Guide Wire with Flex Tip | 10850000491431 | Class III | |
| VIPERWIRE Advance™ Peripheral Guide Wire | 10850000491158 | Class IIa | |
| VIPERWIRE Advance™ Peripheral Guide Wire | 10850000491165 | Class IIa | |
| VIPERWIRE Advance™ Peripheral Guide Wire with Flex Tip | 10850000491370 | Class IIa | |
| VIPERWIRE Advance™ Peripheral Guide Wire with Flex Tip | 10850000491387 | Class IIa | |