Device Description : The ProCatid Embolic Protection System is a temporary embolic protection system, The ProCatid Embolic Protection System is a temporary embolic protection system, filtering distal to the intervention site. It is provided sterile and for single use. The system is a rapid exchange, pre-loaded filter that can be used with commercially available 0.014" guide wires. After the guidewire of choice is properly located in the target vessel, the filter is delivered, locked and deployed on the wire, at any location according to physician's discretion. The locking mechanism is remotely activated, allowing the stand-alone filter unit to be positioned in any location along the vessel without compromising wire performance and support. At the end of the procedure, the filter is retrieved along with the wire.SYSTEM COMPONENTS:1 Delivery Catheter DI 7290015512022 1 Retrieval Catheter DI 7290015512039
Device Class : 2
Duns Number: 531908965
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ProCatid Delivery Catheter is supplied as part of the Wirion System Kit, DI The ProCatid Delivery Catheter is supplied as part of the Wirion System Kit, DI 7290015512015Delivery Catheter: Contains and delivers a Filter Unit, locks it onto the guide wire using the Activating Handle and deploys it in the target vessel. The Filter Unit is made of a filter membrane and a Nitinol frame. A 5cc syringe with a soft needle is supplied for flushing the system prior to use.
Device Class : 2
Duns Number: 531908965
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Retrieval Catheter is supplied as part of the ProCatid System Kit, DI 729001 The Retrieval Catheter is supplied as part of the ProCatid System Kit, DI 7290015512015Retrieval Catheter: Retrieves the Filter Unit with the captured emboli and debris after the therapeutic procedure is completed.
Device Class : 2
Duns Number: 531908965
Premarket Exempt : No
Prescription Use : Yes
Device Description : The WIRION Embolic Protection System is a temporary embolic protection system, f The WIRION Embolic Protection System is a temporary embolic protection system, filtering distal to the intervention site. It is provided sterile and for single use. The system is a rapid exchange, pre-loaded filter that can be used with commercially available 0.014" guide wires. After the guidewire of choice is properly located in the target vessel, the filter is delivered, locked and deployed on the wire, at any location according to physician's discretion. The locking mechanism is remotely activated, allowing the stand-alone filter unit to be positioned in any location along the vessel without compromising wire performance and support. At the end of the procedure, the filter is retrieved along with the wire.SYSTEM COMPONENTS:1 Delivery Catheter DI 72900155120202 1 Retrieval Catheter DI 72900155120309
Device Class : 2
Duns Number: 531908965
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Wirion Delivery Catheter is supplied as part of the Wirion System Kit, DI 72 The Wirion Delivery Catheter is supplied as part of the Wirion System Kit, DI 72900155120105Delivery Catheter: Contains and delivers a Filter Unit, locks it onto the guide wire using the Activating Handle and deploys it in the target vessel (Fig. 1). The Filter Unit is made of a filter membrane and a Nitinol frame. A 5cc syringe with a soft needle is supplied for flushing the system prior to use.
Device Class : 2
Duns Number: 531908965
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Retrieval Catheter is supplied as part of the Wirion System Kit, DI 72900155 The Retrieval Catheter is supplied as part of the Wirion System Kit, DI 72900155120105Retrieval Catheter: Retrieves the Filter Unit with the captured emboli and debris after the therapeutic procedure is completed.
Device Class : 2
Duns Number: 531908965
Premarket Exempt : No
Prescription Use : Yes