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PRISMAFLEX TPE 2000 Set

by Vantive US Healthcare, LLC

PMA P830063

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P830063↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP830063 Date27 May 1986ApprovedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1231-2026 FDA Class II initiated 6 Jan 2026

    There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade Name
Gambro Fiber Plasmafilter
Generic Name
Separator for therapeutic purposes, membrane automated blood cell/plasma
PMA Number
FDA Product Code
MDP
Device Class
Class III
Advisory Committee
Gastroenterology, Urology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Prismaflex TPE 2000 Set is a membrane automated blood cell/plasma separator designed for therapeutic plasma separation. It is intended to remove circulation plasma components or protein-bound toxins from whole blood in a clinical setting by separating plasma from cellular elements.

This device is supplied as a single-use, sterile set and is regulated under an FDA Premarket Approval (PMA). It is used in conjunction with a plasmafilter membrane system, typically within urology or gastroenterology procedures, and requires appropriate storage and handling as a medical device classified under Class III. The set includes all necessary components for plasma separation as part of a therapeutic apheresis process.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical specialties commonly use the Prismaflex TPE 2000 Set in their procedures?

    The Prismaflex TPE 2000 Set is primarily utilized within **urology and gastroenterology** procedures, as indicated by its advisory committee designation (GU). It is designed for therapeutic plasma separation, which can be relevant in treating conditions where plasma components or toxins need removal, such as certain metabolic disorders or toxin overloads.

  • Is the Prismaflex TPE 2000 Set intended for single-use or can it be reused?

    The Prismaflex TPE 2000 Set is explicitly supplied as a **single-use, sterile set**. This design ensures patient safety and hygiene, as reuse could compromise sterility and device integrity, which is critical for blood separation procedures.

  • What specific therapeutic purpose does the Prismaflex TPE 2000 Set serve in clinical settings?

    The device is intended for **therapeutic plasma separation**, allowing healthcare providers to remove circulation plasma components or **protein-bound toxins** from whole blood. This process is part of an **apheresis procedure**, where plasma is isolated from cellular elements for therapeutic intervention.

  • How is the Prismaflex TPE 2000 Set regulated by the FDA, and what does that mean for its use?

    The Prismaflex TPE 2000 Set is regulated under an **FDA Premarket Approval (PMA)** process, classified as a **Class III device**. This means it undergoes rigorous review to ensure safety and effectiveness before clinical use, and it is only approved for **therapeutic plasma separation from whole blood** as described in its authorized indications.

  • Does the Prismaflex TPE 2000 Set require pairing with another system, and if so, what is it?

    Yes, the Prismaflex TPE 2000 Set is designed to be used **in conjunction with a plasmafilter membrane system**, specifically the **Gambro Fiber Plasmafilter**. This pairing ensures proper plasma separation functionality during therapeutic apheresis procedures.