Cannula, Intravenous, R

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

510(k) Number

K770512 ↗

FDA Product Code

DQR

Device Class

Class II

Regulation

21 CFR Part 870.1300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lancer Glucose Rate Reagent Kit

  Class II

  FDA 510(k) K801071 Active Cleared 23 May 1980

• Blood Collection Tube, Lavender

  Class II

  FDA 510(k) K771052 Active Cleared 27 Jun 1977

• Catheter, Argyle Thoracic

  Class I

  FDA 510(k) K760351 Active Cleared 23 Aug 1976

• Sump Drain, W/Filter, Argyle Edlich

  Class I

  FDA 510(k) K770442 Active Cleared 30 Mar 1977

• Lancer L-Ina Human Reference Serum

  Class II

  FDA 510(k) K792013 Active Cleared 13 Nov 1979

• Reagent Kit, Lancer Glucose

  Class I

  FDA 510(k) K790197 Active Cleared 12 Mar 1979

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• What clinical settings is this intravenous cannula designed for and how is it typically used?

  This intravenous cannula is designed for use in clinical settings such as hospitals, outpatient care, and emergency medicine. It is intended for inserting into a vein to administer fluids, medications, or blood products, providing a secure pathway for infusion therapies while minimizing trauma to the vein wall. Its design ensures reliability in various patient care environments where vascular access is required.

• Is this cannula intended for single-use or can it be reused?

  This cannula is explicitly supplied as a single-use, sterile device. It is not designed or intended for reuse, adhering to standard medical practice for intravenous access to ensure patient safety and prevent infection.

• What regulatory pathway was followed for this device’s clearance, and what does that mean for its use?

  This device received FDA clearance through a Traditional 510(k) pathway, determined to be Substantially Equivalent to a predicate device. This means it underwent review by the FDA’s Cardiovascular (CV) Advisory Committee to ensure it meets safety and effectiveness standards for intravenous use, allowing it to be legally marketed and used in clinical practice as described.

• Are there any specific size or model variations available for this cannula?

  The provided regulatory data does not specify any details about size variations, model numbers, or packaging configurations for this cannula. For precise sizing options or model-specific details, consulting the manufacturer’s product catalog or technical documentation would be necessary.