The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Remove Labeling Restrict From Guide Wires.
| Device ID | K912293 |
| 510k Number | K912293 |
| Device Name: | REMOVE LABELING RESTRICT FROM GUIDE WIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
| Contact | Alex Ball |
| Correspondent | Alex Ball TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-23 |
| Decision Date | 1991-12-05 |