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NMI PICC Catheter

by Navilyst Medical, Inc.

510(k) K091261

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK091261 Date12 May 2009ClearedStatusActive

Recalls

5 recalls · FDA

    • Terminated Z-0595-2019 FDA Class II initiated 16 Oct 2018

    Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use beyond the validated expiry date.

  • 4 recalls, same reason

    • Terminated Z-0242-2018 FDA Class II initiated 28 Nov 2016
    • Terminated Z-0241-2018 FDA Class II initiated 28 Nov 2016
    • Terminated Z-0240-2018 FDA Class II initiated 28 Nov 2016
    • Terminated Z-0243-2018 FDA Class II initiated 28 Nov 2016

    Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer. Greatbatch Medical determined that the products listed in their 11/11/2016 Recall Notification have the potential for the handles to detach from the sheath during use. NMI has confirmed that the affected sheaths, Greatbatch Model Number 10890-006, had been included in packaged Xcela and BioFlo PICC Kits.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Nmi Picc
510(k) Number
FDA product code
LJS
Device class
Class II
Regulation
21 CFR Part 880.5970
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The NMI PICC Catheter is a Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, designed for peripheral insertion into the central venous system. It provides sustained vascular access for intravenous therapies, including fluid administration, medication delivery, nutrient infusion, and blood sampling. The device is engineered for long-term use, ensuring reliable access while minimizing complications associated with repeated peripheral venipuncture.

This catheter is supplied as a sterile, single-use device intended for hospital settings, including general medical wards. It is classified as Class II under FDA regulations and holds a 510(k) clearance for special review in the General Hospital category. Available in multiple sizes (as referenced by FEI numbers), it must be stored under sterile conditions and handled according to aseptic techniques. No MRI safety information is specified, and its reusable status is not applicable due to single-use design.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What is the NMI PICC Catheter designed for?

    The NMI PICC Catheter is a long-term intravascular device (greater than 30 days) intended for peripheral insertion into the central venous system. It provides reliable vascular access for sustained intravenous therapies, including fluid administration, medication delivery, nutrient infusion, and blood sampling. This design minimizes complications from repeated peripheral venipuncture, making it ideal for patients requiring prolonged treatment in hospital settings.

  • How is the NMI PICC Catheter supplied and what are its sterility requirements?

    The NMI PICC Catheter is supplied as a sterile, single-use device. It must be handled using aseptic techniques to maintain sterility, as required for hospital environments like general medical wards. The packaging ensures protection until immediate clinical use, and reuse is not applicable due to its single-use classification.

  • What sizes or models are available for the NMI PICC Catheter?

    The NMI PICC Catheter comes in multiple sizes, each identified by a unique FEI (Federal Equipment Identifier) number. These include references like 2527072, 3009211636, 1018233, and others listed in the regulatory records. The specific size or model should be selected based on patient anatomy and clinical requirements, ensuring proper fit and functionality for central venous access.

  • How should the NMI PICC Catheter be stored?

    The NMI PICC Catheter must be stored under sterile conditions to preserve its integrity and prevent contamination. Storage should follow manufacturer guidelines, typically in sealed, sterile packaging until ready for use. Avoid exposure to moisture, extreme temperatures, or direct light, as these factors could compromise sterility or device performance.

  • Is MRI safety information provided for the NMI PICC Catheter?

    The provided device data does not specify MRI safety information for the NMI PICC Catheter. Clinicians should consult the manufacturer’s labeling or additional documentation for guidance on MRI compatibility before use in magnetic resonance imaging procedures. Always prioritize patient safety by verifying device suitability for any planned imaging.