The following data is part of a premarket notification filed by Plan 1 Health, S.r.l. with the FDA for Painfusor Catheter.
| Device ID | K111031 |
| 510k Number | K111031 |
| Device Name: | PAINFUSOR CATHETER |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | PLAN 1 HEALTH, S.R.L. 2400 VIA CARILLO Palos Verdes Estates, CA 90274 |
| Contact | Sigi Caron |
| Correspondent | Sigi Caron PLAN 1 HEALTH, S.R.L. 2400 VIA CARILLO Palos Verdes Estates, CA 90274 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-14 |
| Decision Date | 2011-07-08 |
| Summary: | summary |