The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Theratek Group Exchange Catheter.
| Device ID | K904680 |
| 510k Number | K904680 |
| Device Name: | THERATEK GROUP EXCHANGE CATHETER |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | DOW CORNING WRIGHT 14320 NW 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Mcgurk Burleson |
| Correspondent | Mcgurk 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 | 1990-10-15 |
| Decision Date | 1990-12-27 |