Delta Med SpA
FDA Regulatory Profile
Delta Med SpA appears in FDA public data with 11 recalls, 4 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2303-2021, Class II) was initiated on June 21, 2021. Its most recent 510(k) clearance was granted on August 26, 2020.
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 4
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2303-2021 | Class II | NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822 | June 21, 2021 |
| Z-2295-2021 | Class II | DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 384 | June 21, 2021 |
| Z-2297-2021 | Class II | DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 | June 21, 2021 |
| Z-2296-2021 | Class II | DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) | June 21, 2021 |
| Z-2299-2021 | Class II | NEO DELTA Self Safe, I.V. Catheter REF 3738222 | June 21, 2021 |
| Z-2301-2021 | Class II | NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522 | June 21, 2021 |
| Z-2300-2021 | Class II | NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units | June 21, 2021 |
| Z-2305-2021 | Class II | WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W | June 21, 2021 |
| Z-2298-2021 | Class II | DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3 | June 21, 2021 |
| Z-2304-2021 | Class II | NEO DELTA SELFSAFE PUR T, I.V. Catheter: | June 21, 2021 |
| Z-2302-2021 | Class II | NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122 | June 21, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K200373 | Deltaven Fast Flash Closed I.V. Catheter Systems | August 26, 2020 |
| K171530 | Deltaven XiV Max, Deltaven XiV Max FF | December 21, 2017 |
| K140175 | INTRAVASCULAR ADMINISTRATION SET | August 5, 2014 |
| K121007 | NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 | December 28, 2012 |