510(k) K200373 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Deltaven Fast Flash Closed I.V. Catheter Systems
| Applicant | Delta Med Spa, Viadana, IT |
| Decision | Substantially Equivalent, Aug 26, 2020 |
| Received | Feb 14, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200373
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.