Delta Med SpA
Delebio Sondrio, IT
Delta Med SpA appears in FDA device records in Delebio Sondrio, IT. FDA records list 4 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 11 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Delta Med SpA between 2012 and 2020. The busiest year on record is 2012, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2014 | 1 |
| 2017 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200373 | Deltaven Fast Flash Closed I.V. Catheter Systems | FOZ | Substantially Equivalent | |
| K171530 | Deltaven XiV Max, Deltaven XiV Max FF | FOZ | Substantially Equivalent | |
| K140175 | INTRAVASCULAR ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K121007 | NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 | FOZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004967767 | 3004967767 | DELTA MED SPA | Strada Provinciale per Dubino 10, Delebio Sondrio 23014 IT | 2026 | |
| 3006846316 | 3006846316 | Delta Med SpA | via Guido Rossa 20, viadana Mantova 46019 IT | 2026 | |
| 3010754844 | 3010754844 | Delta Med SpA | Street Emilio Gino Segre 6, Sorbolo Levante di Brescello Reggio Emilia 42041 IT | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2305-2021 | WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Class II | Open, Classified | |
| Z-2304-2021 | NEO DELTA SELFSAFE PUR T, I.V. Catheter: | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Class II | Open, Classified | |
| Z-2303-2021 | NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822 | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Class II | Open, Classified | |
| Z-2302-2021 | NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122 | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Class II | Open, Classified | |
| Z-2301-2021 | NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522 | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Class II | Open, Classified | |
| Z-2300-2021 | NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Class II | Open, Classified | |
| Z-2299-2021 | NEO DELTA Self Safe, I.V. Catheter REF 3738222 | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Class II | Open, Classified | |
| Z-2298-2021 | DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072 | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Class II | Open, Classified | |
| Z-2297-2021 | DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573 | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Class II | Open, Classified | |
| Z-2296-2021 | DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572 | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Class II | Open, Classified | |
| Z-2295-2021 | DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272 | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain