Delta Med SpA
Medical device manufacturer in Viadana, Ital.
4510(k) clearances
0PMA approvals
11recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K200373 | Deltaven Fast Flash Closed I.V. Catheter SystemsFOZ · Traditional | 08/26/2020SE |
| K171530 | Deltaven XiV Max, Deltaven XiV Max FFFOZ · Traditional | 12/21/2017SE |
| K140175 | Intravascular Administration SetFPA · Traditional | 08/05/2014SE |
| K121007 | Neo Delta Self Safe T, Neo Delta Self Safe T, Neo Delta Self Safe 1, Neo Delta Self Safe 1FOZ · Traditional | 12/28/2012SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2305-2021 Class II | WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475WProblems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2304-2021 Class II | NEO DELTA SELFSAFE PUR T, I.V. Catheter:Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2303-2021 Class II | NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2302-2021 Class II | NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2301-2021 Class II | NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2300-2021 Class II | NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 unitsProblems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2299-2021 Class II | NEO DELTA Self Safe, I.V. Catheter REF 3738222Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2298-2021 Class II | DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072…Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2297-2021 Class II | DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b)…Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2296-2021 Class II | DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF…Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |
| Z-2295-2021 Class II | DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272…Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 06/21/2021Open, Classified |