Product code LPC
- Device name
- Device, Angioplasty, Laser, Coronary
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P910001S124 | ELCA Coronary Atherectomy Catheters | Spectranetics Corp. | 2026-02-06 |
| P910001S125 | ELCA Coronary Atherectomy Catheters | Spectranetics Corp. | 2025-12-18 |
| P910001S123 | Philips Laser System | Spectranetics Corp. | 2024-11-21 |
| P910001S122 | ELCA Coronary Angioplasty Laser Sheaths, Philips Laser System (CVX/PLS) | Spectranetics Corp. | 2024-09-05 |
| P910001S121 | Philips Laser System | Spectranetics Corp. | 2023-10-30 |
| P910001S120 | Philips Laser System | Spectranetics Corp. | 2023-08-31 |
| P910001S119 | ECLA Coronary Atherectomy Catheters | Spectranetics Corp. | 2023-05-04 |
| P910001S118 | ELCA Coronary Atherectomy Catheters | Spectranetics Corp. | 2023-03-21 |
| P910001S117 | ELCA Coronary Laser Catheters | Spectranetics Corp. | 2022-10-21 |
| P910001S116 | ELCA Coronoary Laser Atherectomy Catheter | Spectranetics Corp. | 2022-08-19 |
| P910001S115 | Philips Laser System | Spectranetics Corp. | 2022-05-05 |
| P910001S114 | ELCA Coronary Atherectomy Catheters | Spectranetics Corp. | 2022-02-24 |
| P910001S112 | Spectranetics Laser Sheath (SLS) | Spectranetics Corp. | 2021-09-02 |
| P910001S113 | ELCA Coronary Atherectomy Catheter | Spectranetics Corp. | 2021-05-11 |
| P910001S111 | Spectranetics CVX-300 Excimer Laser System | Spectranetics Corp. | 2020-12-22 |
| P910001S110 | CVX-3000 Excimer Lasert System and ELCA Coronary Atherectomy Catheters | Spectranetics Corp. | 2019-10-21 |
| P910001S109 | CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters | Spectranetics Corp. | 2019-03-20 |
| P910001S108 | SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM | Spectranetics Corp. | 2018-11-16 |
| P910001S107 | CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters | Spectranetics Corp. | 2018-10-15 |
| P910001S106 | CVX-300 and CVX-300-P Excimer Laser Systems | Spectranetics Corp. | 2018-09-25 |
| P910001S105 | ELCA Coronary Atherectomy Catheters | Spectranetics Corp. | 2018-08-14 |
| P910001S089 | CVX-300 and CVX-300-P EXCIMER LASER SYSTEM | Spectranetics Corp. | 2018-07-27 |
| P910001S097 | CVX-300-P Excimer Laser System | Spectranetics Corp. | 2018-06-29 |
| P910001S104 | CVX-300 Excimer Laser System/ELCA Coronary Atherectomy Catheter | Spectranetics Corp. | 2018-05-08 |
| P910001S103 | ELCA Laser Catheters | Spectranetics Corp. | 2018-03-29 |
| P910001S102 | CVX-300 Excimer Laser System | Spectranetics Corp. | 2017-12-22 |
| P910001S099 | ELCA Coronary Laser Atherectomy Catheters | Spectranetics Corp. | 2017-09-21 |
| P910001S098 | ELCA Coronary Laser Atherectomy Catheters | Spectranetics Corp. | 2017-09-01 |
| P910001S096 | ELCA Laser Catheters | Spectranetics Corp. | 2017-08-25 |
| P910001S095 | ELCA Catheters | Spectranetics Corp. | 2017-08-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00813132029937 | Excimer Laser System | Spectranetics Corporation | 2022-10-12 |
| 00813132027452 | Philips Laser System | Spectranetics Corporation | 2021-09-20 |
| M204CVX300PAA0 | CVX-300®-P | Spectranetics Corporation | 2017-01-20 |
| 00813132020019 | ELCA™ | Spectranetics Corporation | 2015-02-06 |
| M204117205AA0 | ELCA™ | Spectranetics Corporation | 2015-02-06 |
| M204117016AA0 | ELCA™ | Spectranetics Corporation | 2015-02-06 |
| M204114009AA0 | ELCA™ | Spectranetics Corporation | 2015-02-06 |
| M204110004AA0 | ELCA™ | Spectranetics Corporation | 2015-02-06 |
| M204110003AA0 | ELCA™ | Spectranetics Corporation | 2015-02-06 |
| M204110002AA0 | ELCA™ | Spectranetics Corporation | 2015-02-06 |
| M204110001AA0 | ELCA™ | Spectranetics Corporation | 2015-02-06 |
| 00813132020002 | ELCA™ | Spectranetics Corporation | 2015-02-06 |
| 00813132020026 | ELCA™ | Spectranetics Corporation | 2015-02-06 |
| 00813132020033 | ELCA™ | Spectranetics Corporation | 2015-02-06 |
| 00813132020040 | ELCA™ | Spectranetics Corporation | 2015-02-06 |
| 00813132020057 | ELCA™ | Spectranetics Corporation | 2015-02-06 |
| 00813132020064 | ELCA™ | Spectranetics Corporation | 2015-02-06 |
| 00813132020071 | ELCA™ | Spectranetics Corporation | 2015-02-06 |
| 00813132020088 | ELCA™ | Spectranetics Corporation | 2015-02-06 |
| M204CVX3000 | Excimer Laser System | Spectranetics Corporation | 2014-08-26 |
| M204CVX300P0 | Excimer Laser System | Spectranetics Corporation | 2014-08-26 |
| M2041100010 | ELCA™ | Spectranetics Corporation | 2014-08-19 |
| M2041100020 | ELCA™ | Spectranetics Corporation | 2014-08-19 |
| M2041200090 | ELCA™ | Spectranetics Corporation | 2014-08-19 |
| M2041200080 | ELCA™ | Spectranetics Corporation | 2014-08-19 |
| M2041172050 | ELCA™ | Spectranetics Corporation | 2014-08-19 |
| M2041170160 | ELCA™ | Spectranetics Corporation | 2014-08-19 |
| M2041140090 | ELCA™ | Spectranetics Corporation | 2014-08-19 |
| M2041100040 | ELCA™ | Spectranetics Corporation | 2014-08-19 |
| M2041100030 | ELCA™ | Spectranetics Corporation | 2014-08-19 |