The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for 8fr Turbo Booster, Guide Catheter, 7fr Turbo Booster, Model 518-063, 518-043.
| Device ID | K071226 |
| 510k Number | K071226 |
| Device Name: | 8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043 |
| Classification | Catheter For Crossing Total Occlusions |
| 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 | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-03 |
| Decision Date | 2007-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20813132020280 | K071226 | 000 |
| 20813132020273 | K071226 | 000 |
| M2045180631 | K071226 | 000 |
| M2045180431 | K071226 | 000 |