Device, Angioplasty, Laser, Coronary

Product Code: LPC

Medical Laser Products

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as LPC

1010Device, Angioplasty, Laser, Coronary

Total Product Life Cycle (TPLC) Devices

1010Device, Angioplasty, Laser, Coronary

FDA Consensus Standards

Device, Angioplasty, Laser, Coronary [32410]21 CFR Unclassified 🔎
Device, Angioplasty, Laser, Coronary [32150]21 CFR Unclassified 🔎

Pre-market Approvals for LPC

P870071LASTAC SYSTEMG V MEDICAL, INC,
P8700438 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASERTRIMEDYNE, INC.
P910001CVX-300 Excimer Laser System and ELCA Coronary Atherectomy CathetersSPECTRANETICS CORP.

Global Unique Device Identification Database

00813132025489Device, Angioplasty, Laser, Coronary
00813132025472Device, Angioplasty, Laser, Coronary
00813132025465Device, Angioplasty, Laser, Coronary
00813132025458Device, Angioplasty, Laser, Coronary
00813132025441Device, Angioplasty, Laser, Coronary
00813132025434Device, Angioplasty, Laser, Coronary
00813132025427Device, Angioplasty, Laser, Coronary
00813132025410Device, Angioplasty, Laser, Coronary
00813132025403Device, Angioplasty, Laser, Coronary
M204120009AA0Device, Angioplasty, Laser, Coronary
M204120008AA0Device, Angioplasty, Laser, Coronary
M204117205AA0Device, Angioplasty, Laser, Coronary
M204117016AA0Device, Angioplasty, Laser, Coronary
M204114009AA0Device, Angioplasty, Laser, Coronary
M204110004AA0Device, Angioplasty, Laser, Coronary

Maude Adverse Events

SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2020-02-13
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2020-02-05
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2019-11-14
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2019-11-06
SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2019-09-09
SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2019-08-06
SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2019-07-19
CORONARY LASER ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2019-07-17
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2019-06-03
ELCA CORONARY LASER ATHERECTOMY CATHETERSPECTRONETICS CORP.2019-05-15
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2019-05-15
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2019-05-13
SPECTRANETICS CORONARY LASER ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2019-05-03
SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2019-03-22
SPECTRANETICS CORONARY LASER ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2019-03-22
SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2019-03-08
SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2019-03-04
SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2019-02-13
SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2019-02-11
SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2019-02-11
ELCA?SPECTRANETICS CORPORATION2019-01-29
SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2018-11-30
SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2018-11-09
SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2018-10-17
SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2018-10-15
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2018-08-09
SPECTRANETICS LASERSPECTRANETICS CORP.2018-06-27
SPECTRANETICS LASER ELCA CATHETERSPECTRANETICS / PHILIPS2018-06-19
SPECTRANETICS LASER ELCA CATHETERSPECTRANETICS PHILIPS2018-06-19
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2018-06-18
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2018-06-13
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2018-05-31
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERTHE SPECTRANETICS CORPORATION2018-05-22
ELCA CORONARY VASCULAR PRODUCTTHE SPECTRANETICS CORPORATION2018-05-11
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2018-03-13
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2018-03-12
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2018-03-12
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2018-03-12
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2018-02-28
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERSPECTRANETICS2017-12-22
SPECTRANETICS CORONARY LASER ATHERECTOMY CATHETERSPECTRANETICS2017-11-27
SPECTRANETICS CORONARY LASER ATHERECTOMY CATHETERSPECTRANETICS2017-11-17
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERSPECTRANETICS2017-08-25
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERSPECTRANETICS2017-08-25
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERSPECTRANETICS2017-08-25
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERSPECTRANETICS2017-08-25
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERSPECTRANETICS2017-08-25
SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERSPECTRANETICS2017-08-25
SPECTRANETICS CORONARY LASER ATHERECTOMY CATHETERSPECTRANETICS2017-08-14
SPECTRANETICS CORONARY LASER ATHERECTOMY CATHETERSPECTRANETICS2017-08-10
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