Cpc, Couble Lumen Cardioplegia-Air Aspi

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

510(k) Number

K832124 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K831440 Active Cleared 3 Jun 1983

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  FDA 510(k) K880877 Active Cleared 31 May 1988

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• Acute Hemodialysis Tray, CAT.#09-9540-7

  Class II

  FDA 510(k) K854612 Active Cleared 3 Jan 1986

• Single Needle Subclavian Vein Access

  Class II

  FDA 510(k) K831401 Active Cleared 3 Jun 1983

See all devices from Med-West, Inc. →

• What is the primary purpose of the CPC Double Lumen Cardioplegia-Air Aspiration Cannula during cardiac surgery?

  The CPC Double Lumen Cardioplegia-Air Aspiration Cannula is designed to deliver cardioplegic fluid to the heart while simultaneously aspirating air from the aorta. This dual-lumen feature helps minimize the risk of air embolism, which can occur during cardioplegia administration in cardiac surgery.

• Is this device intended for reuse in clinical settings, or is it meant for single-use only?

  The device is explicitly intended for single-use in controlled surgical environments like operating rooms. This aligns with standard medical device practices to ensure sterility and patient safety, as it requires sterile packaging and proper handling.

• How is the CPC cannula supplied, and what should clinicians consider when handling it?

  The CPC cannula is supplied in sterile packaging, which is critical for maintaining its integrity before use. Clinicians should follow standard sterile field protocols to prevent contamination, as it is designed for one-time use in surgical procedures.

• What regulatory pathway was followed for FDA clearance of this device, and when was it originally submitted?

  The device received FDA 510(k) clearance (K832124) under the Traditional pathway, with a decision date of August 12, 1983. It was originally submitted to the Cardiovascular (CV) Advisory Committee in June 1983 and is classified as Class II under FDA regulations (product code: DWF).

• Are there specific storage requirements for the CPC cannula before use?

  While the provided data does not specify exact storage conditions, the device is sterile and must be handled per medical device standards to preserve its integrity. It should be stored in its original packaging, protected from contamination, and used within the manufacturer’s recommended timeframe to ensure safety and efficacy.