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Directional Atherectomy Systems - TurboHawk | Medtronic
- https://www.medtronic.com/us-en/healthcare-professionals/products/cardiovascular/directional-atherectomy-systems/turbohawk.html
- The TurboHawk™ Peripheral Plaque Excision System is intended for use in the atherectomy of the peripheral vasculature. The TurboHawk catheter is NOT intended for use in the …
Directional Atherectomy Systems - TurboHawk | Medtronic
- https://europe.medtronic.com/xd-en/healthcare-professionals/products/cardiovascular/directional-atheterectomy-systems/turbohawk.html
- Product Details. The TurboHawk peripheral plaque excision system can maximise lumen gain, above and below the knee, in all lesion morphologies, including calcium.*. Because …
TurboHawk Plus Directional Atherectomy System
- https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-turbohawk-plus-directional-atherectomy-system-due-risk-tip-damage-during-use
DeviceMD - TurboHawk Peripheral Plaque Excision System
- https://mydevicemd.com/medical-device/turbohawk-peripheral-plaque-excision-system
- The TurboHawk catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature. The TurboHawk Catheter is indicated for use in conjunction with the …
Medtronic revives old product line to boost atherectomy …
- https://www.medicaldevice-network.com/comment/medtronic-revives-atherectomy-device/
- On August 24, the FDA announced the successful 510 (k) application of Medtronic’s TurboHawk Plus Directional Atherectomy System, an updated version of its …
Medtronic Recalls TurboHawk Due to HawkOne Recall
- https://www.mddionline.com/regulatory-quality/medtronic-recalls-turbohawk-due-hawkone-recall
- The device is used during procedures intended to remove blockage from peripheral arteries and improve blood flow. There have been 163 complaints, including 55 …
510(k) Premarket Notification
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212027
- Device Classification Name. catheter, peripheral, atherectomy. 22. 510 (k) Number. K212027. Device Name. TurboHawk Plus Directional Atherectomy System. …
Senior Director of Regulatory Affairs 4600 Nathan …
- https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212027.pdf
- TurboHawk Plus catheter contains a connector and cutter positioning lever (thumb switch) designed to fit into the cutter driver. The cutter driver is a battery-driven, internally …
Atherectomy for Lower Extremity Intervention: Why, …
- https://www.acc.org/latest-in-cardiology/articles/2015/06/16/07/58/atherectomy-for-lower-extremity-intervention
- The SilverHawk and TurboHawk devices come in various sizes to enable atherectomy in vessels ranging from a diameter of 1.5 mm to 7 mm. The SilverHawk …
Medtronic Recalls TurboHawk Directional Atherectomy …
- https://www.medscape.com/viewarticle/969998
- Medtronic Recalls TurboHawk Directional Atherectomy System Megan Brooks March 09, 2022 Medtronic has recalled 686 TurboHawk Plus Directional Atherectomy Systems because there is a risk that the...
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