Port-A-Cath Implantable Cath. Sys

• • Terminated Z-0152-2016 FDA Class II ·initiated 14 Sep 2015

  The label on the lid stock of the individual needle packages for a portion of Lot number 46262 contains the incorrect part number, part number description and product image. The part number should be 21-2287-24 Port-A-Cath Plastic Hub Bent Needle.

510(k) Number

K830730 ↗

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 primary function of the Port-A-Cath Implantable Catheter System?

  This device is a subcutaneous, implanted, intravascular infusion port and catheter. It is designed to facilitate the long-term delivery of medications or fluids directly into the vascular system.

• How is this device classified for regulatory purposes?

  The Port-A-Cath is regulated as a Class 2 medical device under regulation number 880.5965. It received FDA 510(k) clearance under reference number K830730.

• Which medical specialty oversees this device?

  The device is categorized under the General Hospital advisory committee, which oversees the regulatory filing and classification for this type of infusion equipment.