The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Spectranetics Quick Cross Extreme Support Catheters.
| Device ID | K092396 |
| 510k Number | K092396 |
| Device Name: | SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS |
| Classification | Catheter, Percutaneous |
| Applicant | SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs, CO 80907 -5159 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings 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 | 2009-08-05 |
| Decision Date | 2009-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20813132020624 | K092396 | 000 |
| 20813132020532 | K092396 | 000 |
| 20813132020549 | K092396 | 000 |
| 20813132020556 | K092396 | 000 |
| 20813132020563 | K092396 | 000 |
| 20813132020570 | K092396 | 000 |
| 20813132020587 | K092396 | 000 |
| 20813132020594 | K092396 | 000 |
| 20813132020600 | K092396 | 000 |
| 20813132020617 | K092396 | 000 |
| M2045180931 | K092396 | 000 |