SPECTRANECTICS VITESSE COS RX CATHETERS, VITESSE E CATHETERS AND EXTREME OTW CATHETERS
FDA premarket approval P910001/S024 · decided 2003-08-08
Approval details
- PMA number
- P910001
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SPECTRANECTICS VITESSE COS RX CATHETERS, VITESSE E CATHETERS AND EXTREME OTW CATHETERS
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Applicant
- Spectranetics Corp.
- Date received
- 2003-02-10
- Decision date
- 2003-08-08
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LPC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- APPROVAL FOR CHANGES TO INSTRUCTIONS FOR USE, INCLUDING CHANGES TO THE CONTRAINDICATIONS SECTION, FOR THE VITESSE COS RX, VITESSE E, AND EXTREME OTW CATHETERS.
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510(k) clearances by this applicant
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|---|---|---|
| LEXICONTURE MECHANICAL DILATOR SHEATH SET (K140047) | Spectranetics Corp. | 2014-04-09 |
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| 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 |