FDA.reportPublic FDA data

Atherectomy laser system beam guide-catheter, peripheral

Definition
A sterile, flexible tube intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the peripheral vasculature for the intraluminal photoablation or debulking of lesion material (blockages or total occlusions), to re-establish blood flow within the vessel. It typically consists of fibreoptic materials with a laser-firing distal end and may be designed for over-the-wire (OTW) or rapid exchange insertion. This is a single-use device.
GUDID devices
112
Last updated
2026-09-04 23:12:27

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07290017590356AuryonEXIMO MEDICAL LTDEXM-4013-H0002026-08-27
07290017590370AuryonEXIMO MEDICAL LTDEXM-4014-H0002026-08-27
07290017590066Auryon Atherectomy Catheter 1.5 mm OTWEXIMO MEDICAL LTDEXM-4001-00002020-05-20
07290017590073Auryon Atherectomy Catheter 0.9 mm OTWEXIMO MEDICAL LTDEXM-4002-00002020-05-20
07290017590080Auryon Atherectomy Catheter 2.0 mm OTWEXIMO MEDICAL LTDEXM-4003-00002020-05-20
07290017590097Auryon Atherectomy Catheter 2.35 mm OTWEXIMO MEDICAL LTDEXM-4004-00002020-05-20
07290017590141Auryon Atherectomy CatheterEXIMO MEDICAL LTDEXM-4001-H0002022-10-04
07290017590158Auryon Atherectomy CatheterEXIMO MEDICAL LTDEXM-4002-H0002022-10-04
07290017590165Auryon Atherectomy CatheterEXIMO MEDICAL LTDEXM-4003-H0002022-10-04
07290017590172Auryon Atherectomy CatheterEXIMO MEDICAL LTDEXM-4004-H0002022-10-04
07290017590288Auryon Atherectomy CatheterEXIMO MEDICAL LTDEXM-4010-H0002023-12-28
07290017590295Auryon Atherectomy CatheterEXIMO MEDICAL LTDEXM-4011-H0002023-12-28
07290017590301Auryon Atherectomy CatheterEXIMO MEDICAL LTDEXM-4010-00002023-12-28
07290017590318Auryon Atherectomy CatheterEXIMO MEDICAL LTDEXM-4011-00002023-12-28
07290017590325Auryon Atherectomy CatheterEXIMO MEDICAL LTDEXM-4012-H0002024-09-16
07290017590332Auryon Atherectomy CatheterEXIMO MEDICAL LTDEXM-4012-00002024-09-16
07290017590264AuryonEXIMO MEDICAL LTDEXM-2002-10002026-06-02
00810060550793Turbo-Power Laser Atherectomy CatheterPhilips Image Guided Therapy Corporation420-0502025-10-21
00810060550809Turbo-Power Laser Atherectomy CatheterPhilips Image Guided Therapy Corporation423-0502025-10-21
00813132020095Turbo-Elite™Spectranetics Corporation410-152AA2015-02-06
00813132020101Turbo-Elite™Spectranetics Corporation410-154AA2015-02-06
00813132020118Turbo-Elite™Spectranetics Corporation414-151AA2015-02-06
00813132020125Turbo-Elite™Spectranetics Corporation414-159AA2015-02-06
00813132020132Turbo-Elite™Spectranetics Corporation417-152AA2015-02-06
00813132020149Turbo-Elite™Spectranetics Corporation417-156AA2015-02-06
00813132020156Turbo-Elite™Spectranetics Corporation420-006AA2015-02-06
00813132020163Turbo-Elite™Spectranetics Corporation420-159AA2015-02-06
00813132020170Turbo-Elite™Spectranetics Corporation423-001AA2015-02-06
00813132020187Turbo-Elite™Spectranetics Corporation425-011AA2015-02-06
00813132020194Turbo Elite™Spectranetics Corporation423-135-01AA2015-02-06
00813132020231Turbo Tandem™Spectranetics Corporation472-110AA2015-02-06
00813132020255Turbo Tandem™Spectranetics Corporation482-110AA2015-02-06
072900175900041.5 mm OTW B-Laser™ catheterEXIMO MEDICAL LTDEXM-4001-00002019-03-22
072900175900110.9 mm OTW B-Laser™ catheterEXIMO MEDICAL LTDEXM-4002-00002019-03-22
072900175900282.0 mm OTW B-Laser™ catheterEXIMO MEDICAL LTDEXM-4003-00002019-03-22
072900175900352.35 mm OTW B-Laser™ catheterEXIMO MEDICAL LTDEXM-4004-00002019-03-22
07290017590042Laser systemEXIMO MEDICAL LTDEXM-2001-10002019-03-22
07290017590059Laser systemEXIMO MEDICAL LTDEXM-2001-11002019-03-22
07290017590110Auryon Laser System 100-120 VacEXIMO MEDICAL LTDEXM-2001-11002020-05-20
00850044399055NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-410-1522025-05-21
00850044399062NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-410-1542025-05-21
00850044399079NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-420-0062025-05-21
00850044399086NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-420-1592025-05-21
00850044399093NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-417-1522025-05-21
00850044399109NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-417-1562025-05-21
00850044399116NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-414-1512025-05-21
00850044399123NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-414-1592025-05-21
00813132029944Turbo-Power Laser Atherectomy CatheterSpectranetics Corporation420-0502023-12-12
00813132029951Turbo-Power Laser Atherectomy CatheterSpectranetics Corporation423-0502023-12-12
B227NRP1301NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-414-1592023-09-15
B227NRP1302NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-417-1562023-09-15
B227NRP1303NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-420-1592023-09-15
B227NRP3681NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-414-1512023-09-15
B227NRP3682NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-417-1522023-09-15
B227NRP3683NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-420-0062023-09-15
B227NRP1300NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-410-1542023-07-12
B227NRP3680NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-410-1522023-07-12
NRP130NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-410-1542022-12-08
NRP368NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCR-410-1522022-08-22
M2044101520Turbo-Elite™Spectranetics Corporation410-1522014-08-28
M2044101540Turbo-Elite™Spectranetics Corporation410-1542014-08-28
M2044141510Turbo-Elite™Spectranetics Corporation414-1512014-08-28
M2044141590Turbo-Elite™Spectranetics Corporation414-1592014-08-28
M2044171520Turbo-Elite™Spectranetics Corporation417-1522014-08-28
M2044171560Turbo-Elite™Spectranetics Corporation417-1562014-08-28
M2044200060Turbo-Elite™Spectranetics Corporation420-0062014-08-28
M2044201590Turbo-Elite™Spectranetics Corporation420-1592014-08-28
M2044230010Turbo-Elite™Spectranetics Corporation423-0012014-08-27
M204423135010Turbo Elite™Spectranetics Corporation423-135-012014-08-27
M2044250010Turbo-Elite™Spectranetics Corporation425-0112014-08-28
M204425135010Turbo Elite™Spectranetics Corporation425-135-012014-08-28
M2044721100Turbo Tandem™Spectranetics Corporation472-1102014-08-19
M2044821100Turbo Tandem™Spectranetics Corporation482-1102014-08-26
172900175900011.5 mm OTW B-Laser™ catheterEXIMO MEDICAL LTDEXM-4001-00002019-03-22
172900175900180.9 mm OTW B-Laser™ catheterEXIMO MEDICAL LTDEXM-4002-00002019-03-22
172900175900252.0 mm OTW B-Laser™ catheterEXIMO MEDICAL LTDEXM-4003-00002019-03-22
172900175900322.35 mm OTW B-Laser™ catheterEXIMO MEDICAL LTDEXM-4004-00002019-03-22
17290017590049Laser systemEXIMO MEDICAL LTDEXM-2001-10002019-03-22
17290017590056Laser systemEXIMO MEDICAL LTDEXM-2001-11002019-03-22
00842362100031DABRA 101 CatheterCatheter Precision, Inc.1012017-10-13