The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Tracker Unibody, Unibody W/side & 25 Side Holes.
| Device ID | K911605 |
| 510k Number | K911605 |
| Device Name: | TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
| Contact | Alexis Ball |
| Correspondent | Alexis Ball TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-10 |
| Decision Date | 1991-07-09 |