CELSITE PEDIATRIC VENOUS SYSTEM— 510(k) K952435

Clearance details

Applicant

B.Braun Medical, Inc.

Product code

Code LJT

Device class

Class 2

Regulation

21 CFR 880.5965

Advisory panel

General Hospital

Date received

1995-05-24

Decision date

1996-04-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Melsungen, DE

• K260916 — FLEXI-PORT Power Injectable Implantable Port2026-06-17
• K252478 — Vaccess CT Low-Profile Power-Injectable Implantable Port +2 more2025-09-05
• K251253 — PowerPort isp Implantable Port +3 more2025-06-18
• K242328 — PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports2024-10-31
• K232737 — PowerPort ClearVUE Slim ECG Enabled Implantable Port +3 more2023-12-08

• K254111 — Irrigation/Urology Sets2026-09-10
• K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15
• K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets2025-07-24
• K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System2024-07-31
• K241845 — Introcan Safety® 2 IV Catheter2024-07-26

Death

234

Injury

6,468

Malfunction

5,326

Other

2

Total

12,030

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-2528-2025 — Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/AClass II·Ongoing·B.Braun Medical S.A.S.·20250721

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K952435.