Celsite Implantable Port with Valved Catheter

• • Terminated Z-2671-2011 FDA Unclassified (pre-2012) ·initiated 13 Apr 2011

  The affected products contain the incorrect winged Surecan needle accessory component in certain Celsite Access Port package configurations. The winged Surecan needle is used to deliver medications and fluids into implanted Celsite Access Ports. Two winged Surecan needle sizes are provided in Celsite U.S. package configurations: 20G (PN 4058631) or 22G (PN 16006593A). A 20G or 22G needle

510(k) Number

K993024 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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

• What is the Celsite Implantable Port with Valved Catheter used for?

  The Celsite Implantable Port with Valved Catheter is designed for vascular access beneath the skin, allowing repeated and reliable venous access. It is specifically intended for mid- to long-term use in general hospital settings to facilitate procedures such as intermittent or continuous venous infusion, chemotherapy administration, parenteral nutrition, blood sampling, and transfusions. The valved catheter helps ensure secure and controlled fluid flow.

• How is the Celsite Implantable Port with Valved Catheter supplied and prepared for use?

  The device is supplied sterile and intended for single-use implantation. It must be handled and stored according to sterile medical device protocols to maintain its integrity and sterility before use. The port is implanted beneath the skin, with the catheter inserted into a vein, ensuring a secure and reliable vascular access point for therapeutic interventions.

• Is the Celsite Implantable Port with Valved Catheter reusable?

  No, the Celsite Implantable Port with Valved Catheter is designed for single-use only. After implantation and use, it should not be reused to prevent contamination and ensure patient safety. Single-use devices are engineered to maintain sterility and functionality for one procedure or patient use.

• What storage requirements apply to the Celsite Implantable Port with Valved Catheter?

  The device must be stored in compliance with sterile medical device protocols. This includes keeping it in its original, unopened packaging until ready for use, protecting it from physical damage, and maintaining appropriate environmental conditions (e.g., temperature and humidity) to preserve sterility and functionality. Always follow manufacturer guidelines for storage to ensure the device remains effective.

• What regulatory clearance does the Celsite Implantable Port with Valved Catheter hold?

  The Celsite Implantable Port with Valved Catheter holds FDA 510(k) clearance under the reference number K993024. This clearance indicates that the device is deemed substantially equivalent to a predicate device and meets regulatory standards for safety and effectiveness. The product code assigned is LJT, and it is classified under Class II medical devices.