The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Stealth Dilation Catheter System.
| Device ID | K893411 |
| 510k Number | K893411 |
| Device Name: | STEALTH DILATION CATHETER SYSTEM |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| 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 | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-02 |
| Decision Date | 1989-09-05 |