The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Trac-wright Trac 10 Catheter.
| Device ID | K915238 |
| 510k Number | K915238 |
| Device Name: | TRAC-WRIGHT TRAC 10 CATHETER |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | DOW CORNING WRIGHT 14320 NW 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Erin Burleson |
| Correspondent | Erin Burleson DOW CORNING WRIGHT 14320 NW 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-21 |
| Decision Date | 1992-02-19 |