The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Tracker(r) Unibody Cath & Tracker 25 Cath,modified.
| Device ID | K915521 |
| 510k Number | K915521 |
| Device Name: | TRACKER(R) UNIBODY CATH & TRACKER 25 CATH,MODIFIED |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-31 |
| Decision Date | 1992-03-23 |