The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Spectranetics Lead Locking Device (lld) #1, #2, #3 Lister.
| Device ID | K990713 |
| 510k Number | K990713 |
| Device Name: | SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER |
| Classification | Stylet, Catheter |
| 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 | DRB |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-04 |
| Decision Date | 1999-10-22 |
| Summary: | summary |