The following data is part of a premarket notification filed by Delta Med Spa with the FDA for Deltaven Xiv Max, Deltaven Xiv Max Ff.
| Device ID | K171530 |
| 510k Number | K171530 |
| Device Name: | Deltaven XiV Max, Deltaven XiV Max FF |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | Delta Med SpA Via Guido Rossa N 20 Viadana, IT 46019 |
| Contact | Raschi Olga |
| Correspondent | Roger Gray Donawa Lifescience Consulting Srl Piazza Albania, N 10 Rome, IT 00153 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-25 |
| Decision Date | 2017-12-21 |
| Summary: | summary |