The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Target Therapeutics Radiopaque Stylet.
| Device ID | K914001 |
| 510k Number | K914001 |
| Device Name: | TARGET THERAPEUTICS RADIOPAQUE STYLET |
| Classification | Stylet, Catheter |
| Applicant | TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
| Contact | Wendy J Zenzen |
| Correspondent | Wendy J Zenzen TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
| Product Code | DRB |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-06 |
| Decision Date | 1991-11-22 |