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FDA 510(k)

TidalPort-AP Implantable Apheresis Vascular Access Port

K-Number: K192291 · 2020-08-20

ApplicantNorfolk Medical Products, Inc.
Decision Date2020-08-20
Product CodePTD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TidalPort-AP Implantable Apheresis Vascular Access Port is a medical device manufactured by Norfolk Medical Products, Inc.. It received FDA 510(k) clearance on 2020-08-20 under approval number K192291. The device is classified under product code PTD. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TidalPort-AP Implantable Apheresis Vascular Access Port?

TidalPort-AP Implantable Apheresis Vascular Access Port is a medical device that received FDA 510(k) clearance on 2020-08-20. It is manufactured by Norfolk Medical Products, Inc.. The 510(k) number is K192291.

When was TidalPort-AP Implantable Apheresis Vascular Access Port approved by the FDA?

TidalPort-AP Implantable Apheresis Vascular Access Port received FDA 510(k) clearance on 2020-08-20, under approval number K192291.

What company makes TidalPort-AP Implantable Apheresis Vascular Access Port?

TidalPort-AP Implantable Apheresis Vascular Access Port is manufactured by Norfolk Medical Products, Inc..

What is the FDA product code for TidalPort-AP Implantable Apheresis Vascular Access Port?

The FDA product code for TidalPort-AP Implantable Apheresis Vascular Access Port is PTD.

Related Clinical Trials

NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT06904651 VADIOR: Advantages of Pre-operative Positioning of Peripherally Inserted Vascular Accesses in DIVA Patients Undergoing Orthopedic Surgery ACTIVE_NOT_RECRUITING NCT07599085 Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures NOT_YET_RECRUITING NCT01866501 Follow-Up Study Validating a Blended Technique to Identify the Proximal Humerus Intraosseous Vascular Access Site COMPLETED NCT07512986 Simulation and Video Training for Phlebitis Recognition and Clinical Decision-Making in Nursing Students NOT_YET_RECRUITING NCT04484220 Ellipsys Vascular Access System Post Market Surveillance (PS) Study COMPLETED

Related PubMed Literature

PMID: 41395509 The Challenges of Vascular Implants: Regulatory Strategies and Biological Responses. Small science (2025)

Related Devices (Code: PTD)

K163001PowerFlow Apheresis I.V. PortC.R. Bard, Inc. K191143PowerFlow Implantable Apheresis IV PortC.R. Bard, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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