| K232260 | Thinline Sheath Introducer | September 27, 2023 |
| K220331 | 091 Balloon Guide Catheter | July 29, 2022 |
| K190338 | 046 Zenith Flex | August 2, 2019 |
| K181354 | 074 Zenith Flex System | October 25, 2018 |
| K172167 | Zenith Flex System | April 19, 2018 |
| K173709 | Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm | January 26, 2018 |
| K172468 | 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm | December 6, 2017 |
| K171672 | 065 Zenith, 074 Zenith | October 19, 2017 |
| K161262 | Super Distal Access (SDA) | September 19, 2016 |