510(k) Report

FDA applicant

B. Braun Interventional Systems, Inc.

Bethlehem, PA3 decisions2013–20172 recalls

FDA records 3 decisions for B. Braun Interventional Systems, Inc. (Bethlehem, PA) from 2013 to 2017: 3 510(k) clearances. Most are in product codes LOX (Catheters, Transluminal Coronary Angioplasty…) and LJT (Port & Catheter, Implanted, Subcutaneous…). Its devices cite 13 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided B. Braun Interventional Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2013: 12016: 12017: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2025

2015: 12025: 1
2013high 1 (2015) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — B. Braun Interventional Systems, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like B. Braun Interventional Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous1decision
  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular1decision
  • DTKFilter, Intravascular, Cardiovascular1decision

Whose devices does it build on?

Its devices cite 13 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K152765Venatech Convertible Vena Cava Filter SystemB. Braun Interventional Systems, Inc. · 20161cites it

What has FDA decided for it lately?

  • K162625SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon CathetersB. Braun Interventional Systems, Inc. · 2017
  • K152765Venatech Convertible Vena Cava Filter SystemB. Braun Interventional Systems, Inc. · 2016
  • K130576Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc. · 20132 recalls

All 3 as B. Braun Interventional Systems, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K130576Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog…Jul 21, 2025Class II
  • K130576Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port…Jun 16, 2015Class II