The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Tunneling Stylet.
| Device ID | K882097 |
| 510k Number | K882097 |
| Device Name: | TUNNELING STYLET |
| Classification | Stylet, Catheter |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Ron R Duck |
| Correspondent | Ron R Duck QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | DRB |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-19 |
| Decision Date | 1988-07-28 |