510(k) K121007 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1
| Applicant | Delta Med Srl, Westmont IL, US |
| Decision | Substantially Equivalent, Dec 28, 2012 |
| Received | Apr 3, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121007
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2021 | Delta Med SpA NEO DELTA Self Safe, I.V. Catheter
REF 3738222 Open, Classified |
FOZ | None listed |
| 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 | None listed |
| 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 | None listed |
| Jun 21, 2021 | Delta Med SpA NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122 Open, Classified |
FOZ | None listed |
| Jun 21, 2021 | Delta Med SpA NEO DELTA SELFSAFE PUR T, I.V. Catheter:
a) REF 3738522
b) REF 3738822 Open, Classified |
FOZ | None listed |
| Jun 21, 2021 | Delta Med SpA NEO DELTA SELFSAFE PUR T, I.V. Catheter: Open, Classified |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.