FDA.reportPublic FDA data

Mechanical atherectomy system, coronary, line-powered

Definition
An assembly of devices intended to mechanically disrupt/remove atheroma plaque from the walls of coronary arteries. It typically includes a mains electricity (AC-powered) energy-producing generator with monitoring functions, a remote control or foot-switch, a handpiece (to which the catheter connects) and a dedicated disposable catheter with a cutting or abrasive head that transmits the mechanical energy to the atheroma. The system may include an integrated irrigation/suction system and includes/requires accessory devices for its function (e.g., saline/lubricant, pump, guidewire).
GUDID devices
75
Last updated
2026-07-15 00:48:14

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08714729893431ROTAPRO™ AdvancerBOSTON SCIENTIFIC CORPORATIONH74939299A02018-07-11
08714729999560ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493946712502020-07-01
08714729999577ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493946715002020-07-01
08714729999584ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493946717502020-07-01
08714729999591ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493946720002020-07-01
08714729999607ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493946721502020-07-01
08714729999614ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493946722502020-07-01
08714729999621ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493946723802020-07-01
08714729999638ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493946725002020-07-01
00191506005559Rotaglide™BOSTON SCIENTIFIC CORPORATIONH7493948300170 2023-11-03
00191506005573Rotaglide™ BOSTON SCIENTIFIC CORPORATIONM00139484001702023-11-03
00191506007119Peripheral ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493951412502022-09-16
00191506007126Peripheral ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493951415002022-09-16
00191506007133Peripheral ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493951417502022-09-16
00191506007140Peripheral ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493951420002022-09-16
00191506007157Peripheral ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493951421502022-09-16
00191506007164Peripheral ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493951422502022-09-16
00191506007171Peripheral ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493951423802022-09-16
00191506007188Peripheral ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493951425002022-09-16
08714729855507Rotaglide™BOSTON SCIENTIFIC CORPORATIONH74923548001602015-01-21
08714729855514Rotaglide™BOSTON SCIENTIFIC CORPORATIONM001141000602017-01-19
10852528005169Diamondback CoronaryCardiovascular Systems, Inc.DBEC-1252014-09-15
10852528005176Diamondback CoronaryCardiovascular Systems, Inc.DBEC-1502014-09-15
10852528005336Diamondback CoronaryCardiovascular Systems, Inc.DBEC-125M2017-05-04
10852528005428Diamondback CoroanryCardiovascular Systems, Inc.DBEC-1252017-11-02
10852528005787Diamondback CoronaryCardiovascular Systems, Inc.DBEC-1252019-02-04
00191506005566Rotaglide™BOSTON SCIENTIFIC CORPORATIONH7493948300170 2023-11-03
00191506005580Rotaglide™ BOSTON SCIENTIFIC CORPORATIONM00139484001702023-11-03
10850026568698Diamondback CoronaryCardiovascular Systems, Inc.DBEC-1252023-06-16
10850026568087Diamondback CoronaryCardiovascular Systems, Inc.DBEC-1252021-05-07
10850026568100Diamondback CoronaryCardiovascular Systems, Inc.DBEC-1252021-05-07
08714729317739RotaLink™ AdvancerBOSTON SCIENTIFIC CORPORATIONH80222782001A02014-09-24
08714729126881RotaLink™ BurrBOSTON SCIENTIFIC CORPORATIONH8022276800502014-09-24
08714729185796RotaLink™ BurrBOSTON SCIENTIFIC CORPORATIONH8022276800702014-09-24
08714729185802RotaLink™ BurrBOSTON SCIENTIFIC CORPORATIONH8022276801602014-09-24
08714729185819RotaLink™ BurrBOSTON SCIENTIFIC CORPORATIONH8022276800602014-09-24
08714729185826RotaLink™ BurrBOSTON SCIENTIFIC CORPORATIONH8022276801502014-09-24
08714729185840RotaLink™ BurrBOSTON SCIENTIFIC CORPORATIONH8022276800402014-09-24
08714729185857RotaLink™ BurrBOSTON SCIENTIFIC CORPORATIONH8022276800302014-09-24
08714729185864RotaLink™ BurrBOSTON SCIENTIFIC CORPORATIONH8022276800202014-09-24
08714729228363RotaLink™ PlusBOSTON SCIENTIFIC CORPORATIONH7492363100302014-09-24
08714729228370RotaLink™ PlusBOSTON SCIENTIFIC CORPORATIONH7492363100402014-09-24
08714729228394RotaLink™ PlusBOSTON SCIENTIFIC CORPORATIONH7492363100602014-09-24
08714729228424RotaLink™ PlusBOSTON SCIENTIFIC CORPORATIONH7492363101602014-09-24
08714729316411RotaLink™ PlusBOSTON SCIENTIFIC CORPORATIONH7492363100202014-09-24
08714729316442RotaLink™ PlusBOSTON SCIENTIFIC CORPORATIONH7492363100502014-09-24
08714729316466RotaLink™ PlusBOSTON SCIENTIFIC CORPORATIONH7492363100702014-09-24
08714729316473RotaLink™ PlusBOSTON SCIENTIFIC CORPORATIONH7492363101502014-09-24
08714729353300Rotablator™ Rotational Atherectomy System Console KitBOSTON SCIENTIFIC CORPORATIONH8022202003912014-09-24
08714729353317Rotablator™BOSTON SCIENTIFIC CORPORATIONH8022243600212014-09-24
08714729719601Rotablator™ Rotational Atherectomy System Console KitBOSTON SCIENTIFIC CORPORATION22020-039-L2014-09-24
08714729837619Rotaglide™BOSTON SCIENTIFIC CORPORATIONH74923548001602015-01-21
08714729838906Peripheral RotaLink® PlusBOSTON SCIENTIFIC CORPORATIONM00114015002016-09-24
08714729838913Peripheral RotaLink® PlusBOSTON SCIENTIFIC CORPORATIONM00114017502016-09-24
08714729838920Peripheral RotaLink® PlusBOSTON SCIENTIFIC CORPORATIONM00114020002016-09-24
08714729838937Peripheral RotaLink® PlusBOSTON SCIENTIFIC CORPORATIONM00114021502016-09-24
08714729838944Peripheral RotaLink® PlusBOSTON SCIENTIFIC CORPORATIONM00114022502016-09-24
08714729838951Peripheral RotaLink® PlusBOSTON SCIENTIFIC CORPORATIONM00114023802016-09-24
08714729838968Peripheral RotaLink® PlusBOSTON SCIENTIFIC CORPORATIONM00114025002016-09-24
08714729847557Rotaglide™BOSTON SCIENTIFIC CORPORATIONM001141000602017-01-19
08714729857808Peripheral RotaLink® PlusBOSTON SCIENTIFIC CORPORATIONM00114012502016-09-24
08714729893356ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493930012502018-07-11
08714729893363ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493930015002018-07-11
08714729893370ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493930017502018-07-11
08714729893387ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493930020002018-07-11
08714729893394ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493930021502018-07-11
08714729893400ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493930022502018-07-11
08714729893417ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493930023802018-07-11
08714729893424ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493930025002018-07-11
08714729975076ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH749393090102018-07-11
08714729975083ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493930901D02018-07-11
08714729975090ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493930901H02018-07-11
08714729975106ROTAPRO™BOSTON SCIENTIFIC CORPORATIONH7493930901R02018-07-11
10850000491356Diamondback CoronaryCardiovascular Systems, Inc.DBEC-1252020-03-05
10850000491363Diamondback CoronaryCardiovascular Systems, Inc.DBEC-1252020-03-05