The following data is part of a premarket notification filed by Carticept Medical, Inc. with the FDA for Navigator Delivery System (navigator Ds).
| Device ID | K122215 |
| 510k Number | K122215 |
| Device Name: | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) |
| Classification | Pump, Infusion |
| Applicant | CARTICEPT MEDICAL, INC. 6120 Windward Pkwy Ste 220 Alpharetta, GA 30005 |
| Contact | Tanya Eberle |
| Correspondent | Tanya Eberle CARTICEPT MEDICAL, INC. 6120 Windward Pkwy Ste 220 Alpharetta, GA 30005 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-25 |
| Decision Date | 2012-10-26 |
| Summary: | summary |