Company ยท IT
Delta Med SpA
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2020. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 26, 2020 | K200373 | Deltaven Fast Flash Closed I.V. Catheter Systems Delta Med Spa, IT | FOZ |
| Dec 21, 2017 | K171530 | Deltaven XiV Max, Deltaven XiV Max FF Delta Med Spa, IT | FOZ |
| Aug 5, 2014 | K140175 | INTRAVASCULAR ADMINISTRATION SET Delta Med Spa, IT | FPA |
| Dec 28, 2012 | K121007 | NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 Delta Med Srl | FOZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2021 | Delta Med SpA WOLF-PAK Self Safe Safety IV Catheter:
a) REF PIVD2010W
b) REF PIV2210W
c) REF PIV2475W Open, Classified |
FOZ | K200373 |
| Jun 21, 2021 | Delta Med SpA NEO DELTA SELFSAFE PUR T, I.V. Catheter: Open, Classified |
FOZ | K121007 |
| Jun 21, 2021 | Delta Med SpA NEO DELTA SELFSAFE PUR T, I.V. Catheter:
a) REF 3738522
b) REF 3738822 Open, Classified |
FOZ | K121007 |
| Jun 21, 2021 | Delta Med SpA NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122 Open, Classified |
FOZ | K121007 |
| Jun 21, 2021 | Delta Med SpA NEO DELTA Self Safe T, I.V. catheter of PUR
a) REF 3779422
b) REF 3769522
c) REF 3708522 Open, Classified |
FOZ | K121007 |
| Jun 21, 2021 | Delta Med SpA NEO DELTA Self Safe 1, I.V. Catheter with PUR
REF 3708122, Lot 00A1160627
5000 units Open, Classified |
FOZ | K121007 |
| Jun 21, 2021 | Delta Med SpA NEO DELTA Self Safe, I.V. Catheter
REF 3738222 Open, Classified |
FOZ | K121007 |
| Jun 21, 2021 | Delta Med SpA DELTAVEN Y, Safety I.V. Catheter in Pur with closed system
a) REF 3832072
b) REF 3810072
c) REF 3842072
d) REF 3852072 Open, Classified |
FOZ | K171530 |
| Jun 21, 2021 | Delta Med SpA 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 3832 Open, Classified |
FOZ | K171530 |
| Jun 21, 2021 | Delta Med SpA 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 Open, Classified |
FOZ | K200373 |
| Jun 21, 2021 | Delta Med SpA DELTAVEN Safety I.V. Catheter in Pur with closed system:
a) REF 3836272
b) REF 3814272
c) REF 3845272
d) REF 3856272 Open, Classified |
FOZ | K171530 |