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Catheter For Crossing Total Occlusions
FDA product code PDU · Class 2 · Cardiovascular
113
Registered devices
1,370
Adverse events
7
Recalls
57
510(k) clearances
Devices with this code
OffRoad™ — BOSTON SCIENTIFIC CORPORATIONELITECROSS Support Catheter — Cordis US Corp.Recanalization System — Bard Peripheral Vascular, Inc.PowerWire Radiofrequency GuideWire Kit — Baylis Medical Technologies IncOffRoad™ — BOSTON SCIENTIFIC CORPORATIONApproach — COOK INCORPORATEDWINGMAN14 — REFLOW MEDICAL, INC.WINGMAN18 — REFLOW MEDICAL, INC.FRONTRUNNER — Cordis US Corp.SoundBite® Curving Tool 14 — Soundbite Medical Solutions IncTurbo-Booster™ — Spectranetics CorporationELITECROSS Support Catheter — Cordis US Corp.Approach — COOK INCORPORATEDCROSSER® — Bard Peripheral Vascular, Inc.PowerWire Pro Radiofrequency Guidewire Kit — Baylis Medical Technologies IncLimFlow ARC — Inari Medical, Inc.TruePath™ — BOSTON SCIENTIFIC CORPORATIONPowerWire 14 Radiofrequency Guidewire Kit — Baylis Medical Technologies IncOcelot IV — AVINGER, INC.BeBack Crossing Catheter — Bentley InnoMed GmbHPowerWire Pro Radiofrequency Guidewire Kit — Baylis Medical Technologies IncEnteer™ — Covidien LPBeBack Crossing Catheter — Bentley InnoMed GmbHRecanalization System — Bard Peripheral Vascular, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-14 | Bard Peripheral Vascular Inc | Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-mi |
| 2020-10-16 | Ra Medical Systems, Inc. | Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may |
| 2020-07-24 | Ra Medical Systems, Inc. | Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury. |
| 2020-01-23 | Ra Medical Systems, Inc. | A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended relea |
| 2019-09-19 | Ra Medical Systems, Inc. | The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf l |
| 2018-02-15 | Ra Medical Systems Inc | Lasers/Catheters did not calibrate during set-up prior to use. |
| 2015-07-22 | Volcano Corporation | Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound G |
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