Occluder, Catheter Tip
FDA product code DQT · Class II (moderate risk) · 21 CFR 870.1370 · Cardiovascular
12510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983927 | GT1 Floppy, GT1 Hi-Per Flex, GT1 Light SupportDQT · Traditional | Arterial Vascular Engineering, Inc. | 03/11/1999SE |
| K945963 | The Omniguide Guiding Catheter with BalloonDQT · Traditional | Micro Interventional Systems, Inc. | 02/08/1995SE |
| K910916 | Cathlab Silicone Occlusion Balloon CatheterDQT · Traditional | Cathlab Corp. | 06/24/1991SE |
| K910339 | Avd Intimax Occlusion CatheterDQT · Traditional | Applied Vascular Devices, Inc. | 05/29/1991SE |
| K880860 | Coronary Ostium Occluder, Catalog Code 32015DQT · Traditional | Dlp, Inc. | 05/26/1988SE |
| K880231 | Modified Pruitt Irrigation & Occlusion CatheterDQT · Traditional | Ideas For Medicine, Inc. | 05/25/1988SE |
| K872090 | The Robicsek - Pruitt Aortic Balloon Occlusion KitDQT · Traditional | Ideas For Medicine, Inc. | 10/30/1987SE |
| K872790 | Perfusion CatheterDQT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/15/1987SE |
| K872154 | Modified Info Inserts for Pruitt Irri.-Occlu. CathDQT · Traditional | Ideas For Medicine, Inc. | 08/03/1987SE |
| K863559 | Uresil Occlusion Balloon CatheterDQT · Traditional | Uresil Corp. | 10/10/1986SE |
| K844918 | Occlusion & Occlusion-IrrigationDQT · Traditional | Clincal Instruments Corp. | 08/05/1985SE |
| K840795 | Acs Sof-T Guide WireeDQT · Traditional | Advanced Cardiovascular Systems, Inc. | 07/02/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1752-2025 Class II | Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.During internal product testing, it was observed that some packages to have incomplete seals (sterile… | LeMaitre Vascular, Inc. | 04/11/2025Open, Classified |
| Z-0268-2014 Class I | ZINGER Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S…Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | Medtronic Vascular | 10/21/2013Terminated |
| Z-0262-2014 Class I | Zinger Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS…Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | Medtronic Vascular | 10/21/2013Terminated |