The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support Catheter, Model 518-017.
| Device ID | K991059 |
| 510k Number | K991059 |
| Device Name: | SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017 |
| Classification | Catheter, Percutaneous |
| Applicant | SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs, CO 80907 -5159 |
| Contact | Michael J Quinn |
| Correspondent | Michael J Quinn SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs, CO 80907 -5159 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-30 |
| Decision Date | 1999-11-16 |
| Summary: | summary |