Argyle Intramedicut Catheter Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K821324 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Labcer Fibrinogen Assay Kit & Calibr.

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• Monoject(R) Trace Element Blood Collection Tube

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• Monoject Samplette Amber Capillary Serum Separator

  Class I

  FDA 510(k) K875061 Active Cleared 12 Jan 1988

• Argyle Turkel Safety Trocar Thoracic Catheter

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  FDA 510(k) K933510 Active Cleared 24 Feb 1994

See all devices from Sherwood Medical Co. →

• What is the Argyle Intramedicut Catheter Kit used for?

  The Argyle Intramedicut Catheter Kit is designed for intravenous procedures requiring stable venous access. It allows for the safe introduction of fluids, medications, or diagnostic agents into the bloodstream, making it suitable for intravenous therapy, blood draws, or angiography. The kit’s components ensure secure catheter placement and reliable fluid administration.

• Is the Argyle Intramedicut Catheter Kit sterile and single-use?

  Yes, the kit is supplied sterile in its packaging and is intended for single-use only. Sterility is maintained until the packaging is opened, so it must be used immediately after removal from the sterile barrier. Reuse is not recommended to prevent contamination and ensure patient safety.

• How should the Argyle Intramedicut Catheter Kit be stored?

  The kit must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. This typically includes keeping it in its original, unopened packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Avoid storing it in areas prone to moisture or chemical exposure.

• What regulatory clearance does the Argyle Intramedicut Catheter Kit hold?

  The device holds FDA 510(k) clearance under the reference number K821324, classified under product code DYB. This clearance confirms it meets regulatory standards for safety and effectiveness as a catheter and related vascular access accessories. No additional MRI safety information is provided.

• Are there different sizes or models available for the Argyle Intramedicut Catheter Kit?

  The provided data does not specify multiple sizes or models for this particular kit. However, the Argyle Intramedicut Catheter Kit is designed for general venous access procedures. For specific patient needs, such as pediatric or large-bore requirements, alternative kits or accessories may be necessary, but these are not detailed in the current description.