The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Target Catheters And Guide Wires For Pediatric Use.
| Device ID | K894084 |
| 510k Number | K894084 |
| Device Name: | TARGET CATHETERS AND GUIDE WIRES FOR PEDIATRIC USE |
| Classification | Catheter, Percutaneous |
| Applicant | TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
| Contact | Marie Daniels |
| Correspondent | Marie Daniels TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-08 |
| Decision Date | 1989-08-17 |