Delta Med SpA

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2299-2021Class IINEO DELTA Self Safe, I.V. Catheter REF 3738222June 21, 2021
Z-2303-2021Class IINEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822June 21, 2021
Z-2295-2021Class IIDELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 384June 21, 2021
Z-2297-2021Class IIDELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 June 21, 2021
Z-2296-2021Class IIDELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) June 21, 2021
Z-2304-2021Class IINEO DELTA SELFSAFE PUR T, I.V. Catheter:June 21, 2021
Z-2298-2021Class IIDELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3June 21, 2021
Z-2305-2021Class IIWOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475WJune 21, 2021
Z-2300-2021Class IINEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 unitsJune 21, 2021
Z-2301-2021Class IINEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522June 21, 2021
Z-2302-2021Class IINEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122June 21, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K200373Deltaven Fast Flash Closed I.V. Catheter SystemsAugust 26, 2020
K171530Deltaven XiV Max, Deltaven XiV Max FFDecember 21, 2017
K140175INTRAVASCULAR ADMINISTRATION SETAugust 5, 2014
K121007NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1December 28, 2012