Deltaven Fast Flash Closed I.V. Catheter Systems— 510(k) K200373

Clearance details

Applicant

Delta Med Spa

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2020-02-14

Decision date

2020-08-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Viadana, IT

• K260432 — Ruby Intravascular Catheter2026-09-02
• K260165 — Unimpregnated Central Venous Catheter2026-08-10
• K261041 — ClearSafe Closed System2026-07-10
• K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter2026-07-09
• K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15

• K171530 — Deltaven XiV Max, Deltaven XiV Max FF2017-12-21
• K140175 — INTRAVASCULAR ADMINISTRATION SET2014-08-05

Death

38

Injury

2,290

Malfunction

25,858

Other

11

Total

28,197

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2296-2021 — 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 3852572Class II·Ongoing·Delta Med SpA·20210621
• Z-2305-2021 — WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475WClass II·Ongoing·Delta Med SpA·20210621

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200373.