The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Target Therapeutics Seeker-16 Steerable Guidewire.
| Device ID | K884198 |
| 510k Number | K884198 |
| Device Name: | TARGET THERAPEUTICS SEEKER-16 STEERABLE GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | TARGET THERAPEUTICS 2944 COLORADO AVE. Santa Monica, CA 90404 |
| Contact | Joni M Snyder |
| Correspondent | Joni M Snyder TARGET THERAPEUTICS 2944 COLORADO AVE. Santa Monica, CA 90404 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-06 |
| Decision Date | 1988-12-13 |