K171530 is an FDA 510(k) clearance for the Deltaven XiV Max, Deltaven XiV Max FF. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Delta Med Spa (Viadana, IT). The FDA issued a Cleared decision on December 21, 2017, 210 days after receiving the submission on May 25, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K171530 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2017 |
| Decision Date | December 21, 2017 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOZ - Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |