Cleared Traditional

TidalPort-AP Implantable Apheresis Vascular Access Port

K192291 · Norfolk Medical Products, Inc. · General Hospital
Aug 2020
Decision
363d
Days
Class 2
Risk

About This 510(k) Submission

K192291 is an FDA 510(k) clearance for the TidalPort-AP Implantable Apheresis Vascular Access Port, a Subcutaneous Implanted Apheresis Port (Class II — Special Controls, product code PTD), submitted by Norfolk Medical Products, Inc. (Skokie, US). The FDA issued a Cleared decision on August 20, 2020, 363 days after receiving the submission on August 23, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K192291 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2019
Decision Date August 20, 2020
Days to Decision 363 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code PTD — Subcutaneous Implanted Apheresis Port
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5965
Definition A Subcutaneous Implanted Apheresis Port Is A Prescription Device Intended For Patient Therapies Requiring Repeated Access To The Vascular System And Long-term Therapeutic Apheresis