The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Turbo Tracker.
| Device ID | K960806 |
| 510k Number | K960806 |
| Device Name: | TURBO TRACKER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | TARGET THERAPEUTICS 47201 LAKEVIEW BLVD. P.O. BOX 5120 Freemont, CA 94538 |
| Contact | Abhi Acharyn |
| Correspondent | Abhi Acharyn TARGET THERAPEUTICS 47201 LAKEVIEW BLVD. P.O. BOX 5120 Freemont, CA 94538 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-28 |
| Decision Date | 1996-05-02 |
| Summary: | summary |