The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036, 518-037 And 518-038.
| Device ID | K033678 |
| 510k Number | K033678 |
| Device Name: | SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038 |
| 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 | 2003-11-24 |
| Decision Date | 2004-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813132020699 | K033678 | 000 |
| M2045180321 | K033678 | 000 |
| 20813132029405 | K033678 | 000 |
| 20813132029399 | K033678 | 000 |
| 20813132029382 | K033678 | 000 |
| 20813132029375 | K033678 | 000 |
| 20813132029368 | K033678 | 000 |
| 20813132029351 | K033678 | 000 |
| 20813132029344 | K033678 | 000 |
| 20813132029337 | K033678 | 000 |
| M2045180331 | K033678 | 000 |
| M2045180341 | K033678 | 000 |
| M2045180351 | K033678 | 000 |
| 00813132020682 | K033678 | 000 |
| 00813132020675 | K033678 | 000 |
| 00813132020668 | K033678 | 000 |
| 00813132020651 | K033678 | 000 |
| 00813132020644 | K033678 | 000 |
| 00813132020637 | K033678 | 000 |
| M2045180381 | K033678 | 000 |
| M2045180371 | K033678 | 000 |
| M2045180361 | K033678 | 000 |
| 20813132029320 | K033678 | 000 |