ClearanceBrief
510(k) K171530 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Deltaven XiV Max, Deltaven XiV Max FF

ApplicantDelta Med Spa, Viadana, IT
DecisionSubstantially Equivalent, Dec 21, 2017
ReceivedMay 25, 2017
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K171530

DateFirm and productCodeLinked 510(k)
Jun 21, 2021Delta 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
FOZNone listed
Jun 21, 2021Delta 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
FOZNone listed
Jun 21, 2021Delta 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
FOZNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.