The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Spectranetics Quick-cross Support2 Catheters, Models 518-065 And 518-066.
| Device ID | K072750 |
| 510k Number | K072750 |
| Device Name: | SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 |
| Classification | Catheter, Percutaneous |
| Applicant | SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs, CO 80907 -5159 |
| Contact | Michael K Handley |
| Correspondent | Michael K Handley SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs, CO 80907 -5159 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-27 |
| Decision Date | 2007-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813132020712 | K072750 | 000 |
| 00813132020705 | K072750 | 000 |
| M2045180661 | K072750 | 000 |
| M2045180651 | K072750 | 000 |
| 20813132029405 | K072750 | 000 |
| 20813132029399 | K072750 | 000 |