The following data is part of a premarket notification filed by Thermedics, Inc. with the FDA for Dermaport Vascular Access Device Model No. 50-1000.
| Device ID | K894131 |
| 510k Number | K894131 |
| Device Name: | DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000 |
| Classification | Catheter, Percutaneous |
| Applicant | THERMEDICS, INC. 470 WILDWOOD ST. P.O. BOX 2697 Woburn, MA 01888 -2697 |
| Contact | Rowland Williams |
| Correspondent | Rowland Williams THERMEDICS, INC. 470 WILDWOOD ST. P.O. BOX 2697 Woburn, MA 01888 -2697 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-13 |
| Decision Date | 1989-09-26 |