| Z-1734-2025 | Class II | GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to int | March 27, 2025 |
| Z-1732-2025 | Class II | B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 T | March 27, 2025 |
| Z-1731-2025 | Class II | GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneo | March 27, 2025 |
| Z-1737-2025 | Class II | Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 | March 27, 2025 |
| Z-1733-2025 | Class II | B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-10 | March 27, 2025 |
| Z-1736-2025 | Class II | Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of gui | March 27, 2025 |
| Z-1735-2025 | Class II | Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-0 | March 27, 2025 |
| Z-1969-2023 | Class II | Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04 | May 8, 2023 |
| Z-1968-2023 | Class II | Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 | May 8, 2023 |
| Z-0568-2021 | Class II | Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10 | November 16, 2020 |
| Z-2565-2018 | Class II | Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e | May 2, 2018 |
| Z-2562-2018 | Class II | Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055 | May 2, 2018 |
| Z-2558-2018 | Class II | 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) B | May 2, 2018 |
| Z-2560-2018 | Class II | 1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC | May 2, 2018 |
| Z-2564-2018 | Class II | TVS LPA, Catalog #: DIL-059-00 | May 2, 2018 |
| Z-2559-2018 | Class II | 1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only | May 2, 2018 |
| Z-2561-2018 | Class II | 1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071- | May 2, 2018 |
| Z-2563-2018 | Class II | Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15, | May 2, 2018 |
| Z-2589-2014 | Class II | GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STE | July 25, 2014 |
| Z-2588-2014 | Class II | GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Us | July 25, 2014 |