FDA 510(k) Applications Submitted by Medtronic Vascular, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K170191 01/23/2017 SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System MEDTRONIC VASCULAR, INC.
K171427 05/15/2017 Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette Medtronic Vascular, Inc.
K182957 10/24/2018 Heli-FX EndoAnchor System Medtronic Vascular, Inc.
K161361 05/16/2016 HawkOne Directional Atherectomy System Medtronic Vascular, Inc.
K171866 06/22/2017 Sentrant Introducer Sheath with Hydrophilic Coating Medtronic Vascular, Inc.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact