SecurAcath SCR-1

Full name

SecurAcath

Generic Name

Wearable percutaneous catheter/tube holder, single-use

Model / Ref / Catalog

SCR-1, 400110, SCR-01, 5F

Primary DI / UDI-DI

00865382000228

Basic UDI-DI

B-00865382000228, 08653820002400XXXG5

FDA Product Code

LJS, OKC, KMK

EMDN Code

C010180,C010299,V9099

GMDN Term

Wearable percutaneous catheter/tube holder, single-use

Device Class

Class IIb EUDAMED

Class II GUDID

Regulation Number

880.5970, 880.5210

Market of Registration

Northern Ireland

Commercial Distribution

In Commercial Distribution

MRI Safety

MR Conditional

Size

Catheter Gauge — 5 French

EUDAMED SRN

US-MF-000009878

Authorised representative

MDSS GmbH DE-AR-000005430

• SecurAcath

  Class IIb

  CE/MDR

• SecurAcath 12F

  Class II

  CE/MDR 28620239803 Active Valid to Dec 2029 CE/MDD +1authorizations

• SecurAcath 8F

  Class II

  CE/MDD CE/MDR 28620239803 Active Valid to Dec 2029 +1authorizations

• Securacath Universal

  Class II

  FDA 510(k) K092306 Active Cleared 9 Jul 2010

• Securacath Catheter, Model SPK01

  Class II

  FDA 510(k) K082047 Active Cleared 30 Sep 2008

• Modification to Securacath, Model: SPK01

  Class II

  FDA 510(k) K083081 Active Cleared 4 Mar 2009

See all devices from Interrad Medical, Inc. →

• What is the primary purpose of the SecurAcath SCR-1 and how does it differ from traditional catheter securement methods?

  The SecurAcath SCR-1 is designed to securely anchor percutaneous catheters *subcutaneously* without relying on sutures or adhesives. Unlike traditional methods that may use tape or stitches, it provides a stable, implantable fixation mechanism beneath the skin to prevent dislodgement, reducing complications tied to catheter instability. This approach minimizes surface-level interventions while ensuring deeper stability.

• Is the SecurAcath SCR-1 reusable or intended for single-use, and how should it be stored before use?

  The SecurAcath SCR-1 is explicitly intended for *single-use only* and is not reusable. It is supplied sterile in its original packaging, so storage should occur in that sealed, sterile condition until ready for implantation. The packaging ensures sterility is maintained until the device is opened for use.

• Can the SecurAcath SCR-1 be used in MRI environments, and what materials does it avoid?

  Yes, the SecurAcath SCR-1 is classified as *MRI-safe*, meaning it can be used in MRI environments without interference or risk. Additionally, the device is manufactured without latex and lacks active components, addressing common allergens and compatibility concerns in clinical settings.

• What regulatory pathways has the SecurAcath SCR-1 followed, and what does this mean for its use in clinical settings?

  The SecurAcath SCR-1 has obtained *FDA 510(k) clearance* (K210629) and complies with the *Medical Device Directive (MDD)*. This clearance indicates the device has been evaluated as substantially equivalent to a predicate and meets FDA standards for safety and effectiveness. Clinically, this means it adheres to rigorous regulatory scrutiny for subcutaneous implantation and securement applications.

• Are there multiple models of the SecurAcath available, or is the SCR-1 the only version?

  As of the available data, the *only model* of the SecurAcath is the SCR-1. There are no additional variants or sizes listed, so clinicians should confirm this is the correct model for their specific patient or procedural needs before use.