Power Injectable Implantable Infusion Port With Silicone Lumen (Attachable and Pre-Attached)

• • Terminated Z-1626-2012 FDA Not yet classified ·initiated 12 Apr 2012

  50 trays of Dignity Low Profile CT Port were labeled as Dignity Mid-Sized CT Port.

• • Terminated Z-1868-2012 FDA Class II ·initiated 2 Apr 2012

  Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.

• • Terminated Z-2235-2010 FDA Unclassified (pre-2012) ·initiated 2 Jul 2010

  Recalled product was packaged with the incorrect port and does not match the label. The kit is labeled as a 6.6F "Dignity" Low Profile CT Port. The kit contains a 6.6F "Pro-Fuse" Low Profile CT Port.

510(k) Number

K070003 ↗

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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• What is the Power Injectable Implantable Infusion Port with Silicone Lumen used for?

  This device is used for repeated vascular access, allowing power injection of contrast media at rates up to 5 ml/s when used with a 19 or 20 gauge power injectable needle, as well as infusion of medications, intravenous fluids, parenteral nutrition, solutions, blood products, and withdrawal of blood samples.

• How is the Power Injectable Implantable Infusion Port supplied and is it sterile?

  The device is supplied by Medcomp as a sterile, implantable system consisting of a subcutaneous reservoir connected to a long-term intravascular catheter with a silicone lumen, designed for single-patient use and implanted surgically for long-term access.

• What regulatory pathway was used for the Power Injectable Implantable Infusion Port with Silicone Lumen?

  The device received FDA 510(k) clearance under K070003, determined to be substantially equivalent to a predicate device, with a traditional clearance type and product code LJT for implanted subcutaneous intravascular ports.