TERUMO SURFLO(R) I.V. CATHETER— 510(k) K891087

Clearance details

Applicant

Terumo Medical Corp.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

1989-03-01

Decision date

1989-06-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Elkton, MD, US

• 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

• K111606 — PINNACLE PRECISION ACCESS SYSTEM2011-10-03
• K111556 — GLIDECROSS SUPPORT CATHETER2011-07-29
• K110540 — TERUMO SUPPORT CATHETER2011-05-13
• K102008 — GLIDESHEATH2010-07-21
• K091329 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH2009-05-29

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-1896-2017 — SurFlo IV CatheterClass II·Terminated·Terumo Medical Corporation·20150805

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K891087.