The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Spectranetics 0.035 Support Catheter, Model 518-028.
| Device ID | K022138 |
| 510k Number | K022138 |
| Device Name: | SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 |
| Classification | Catheter, Percutaneous |
| Applicant | SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs, CO 80907 -5159 |
| Contact | Michael J Ryan |
| Correspondent | Michael J Ryan 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 | 2002-07-02 |
| Decision Date | 2002-09-23 |
| Summary: | summary |