SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
FDA premarket approval P910001 · decided 1993-02-19
Approval details
- PMA number
- P910001
- Trade name
- SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Applicant
- Spectranetics Corp.
- Date received
- 1991-02-08
- Decision date
- 1993-02-19
- Days to decision
- 742 days
- Decision code
- APPR
- Product code
- LPC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- APPROVAL FOR THE SPECTRANETICS CVX-300(TM) EXCIMER LASER SYSTEM, INCLUDING THE MODELS PC1014 AND PC1017 LASER CATHETERS. THIS SYSTEM IS INDICATED FOR USE IN PATIENTS WITH SINGLE OR MULTIVESSEL CORONARY ARTERY DISEASE EITHER AS A STAND ALONE MODALITY OR IN CONJUNCTION WITH PERCUTANEOUS TRANSLUMINAL CORONARY BALLOON ANGIOPLASTY (PTCA) AND WHO ARE ACCEPTABLE CANDIDATES FOR CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. ADJUNCTIVE BALLOON ANGIOPLASTY WAS PERFORMED, AT THE CLINICAL INVESTIGATOR'S DISCR
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LEXICONTURE MECHANICAL DILATOR SHEATH SET (K140047) | Spectranetics Corp. | 2014-04-09 |
| 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 (K123632) | Spectranetics Corp. | 2013-01-25 |
| 8FR TURBO - TANDEM SYSTEM (K112032) | Spectranetics Corp. | 2011-10-17 |
| TORQMAX SHEATH GRIP ACCESSORY (K093257) | Spectranetics Corp. | 2010-03-26 |
| TURBO-TANDEM SYSTEM MODEL 472-110 (K094036) | Spectranetics Corp. | 2010-01-25 |
| SPECTRANETICS VISISHEATH DILATOR SHEATH (K092378) | Spectranetics Corp. | 2009-11-02 |
| SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS (K092396) | Spectranetics Corp. | 2009-09-04 |
| SPECTRANETICS TURBO-TANDEM SYSTEM (K091299) | Spectranetics Corp. | 2009-07-01 |