The following data is part of a premarket notification filed by Astra Tech, Inc. with the FDA for Lofric Primo, Lofric Hydro-kit.
| Device ID | K122078 |
| 510k Number | K122078 |
| Device Name: | LOFRIC PRIMO, LOFRIC HYDRO-KIT |
| Classification | Catheter, Straight |
| Applicant | ASTRA TECH, INC. 11234 EL CAMINO REAL, STE 200 San Diego, CA 92130 |
| Contact | Allison C Komiyama |
| Correspondent | Allison C Komiyama ASTRA TECH, INC. 11234 EL CAMINO REAL, STE 200 San Diego, CA 92130 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-16 |
| Decision Date | 2012-10-31 |
| Summary: | summary |