Celsite Brachial Venous Port

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Celsite(Tm) Brachial Venous Port

510(k) Number

K945752 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Trumpet Valve

  Class II

  FDA 510(k) K911415 Active Cleared 3 Jun 1991

• Comfort-Q Subcutaneous Injection Sets

  Class II

  FDA 510(k) K946170 Active Cleared 3 Nov 1995

• Dualtherm(R) Cardiac Output Computer

  Class II

  FDA 510(k) K925285 Active Cleared 21 Jul 1993

• Charged Supor(R) Filter Extension Set

  Class II

  FDA 510(k) K940980 Active Cleared 14 Jul 1994

• Celsite(Tm) Dual Venous System

  Class II

  FDA 510(k) K945551 Active Cleared 21 Apr 1995

• Dispensing Pin with One-Way Valve

  Class II

  FDA 510(k) K943181 Active Cleared 29 Sep 1994

See all devices from B. Braun of America, Inc. →

• What types of medical settings is the Celsite Brachial Venous Port intended for, and how is it typically used?

  The Celsite Brachial Venous Port is designed specifically for use in hospital settings and is intended for long-term intravenous access. It is implanted beneath the skin and connects to a catheter, allowing reliable administration of fluids, medications, or nutrients directly into the bloodstream. This makes it ideal for patients requiring frequent or prolonged intravenous therapy, such as chemotherapy, antibiotics, or parenteral nutrition.

• Is the Celsite Brachial Venous Port single-use or reusable, and what does that mean for its handling?

  The Celsite Brachial Venous Port is sterile and intended for single-use implantation only. This means it should not be reused after initial implantation, as reuse could compromise sterility and patient safety. Proper sterile techniques must be followed during implantation and subsequent access to minimize infection risk.

• Does the Celsite Brachial Venous Port come in different sizes, and if so, how might that affect its selection?

  While the exact sizes are not detailed in the provided data, the Celsite Brachial Venous Port is available in specific sizes as referenced in the regulatory submission. Size selection is typically based on patient anatomy, catheter length requirements, and clinical needs to ensure proper placement and functionality. Consulting the manufacturer’s sizing guidelines or a healthcare professional is recommended to choose the appropriate model.

• Can the Celsite Brachial Venous Port be used safely in MRI procedures, and what considerations should be taken?

  Yes, the Celsite Brachial Venous Port is designed for MRI safety compliance, meaning it can be used in MRI procedures without posing significant risks. However, it is critical to follow MRI facility protocols and ensure the port is compatible with the specific MRI machine settings to avoid potential heating or displacement. Always verify with the MRI technician before imaging.

• How should the Celsite Brachial Venous Port be stored before implantation, and what are the key storage requirements?

  The Celsite Brachial Venous Port is supplied sterile, so it must be stored in its original, unopened packaging to maintain sterility until use. Storage should follow the manufacturer’s instructions, typically in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination or exposure to moisture, as this could compromise the device’s integrity before implantation.