Dideco Flexible Reservoir -- Product Designation 5063

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

510(k) Number

K945065 ↗

FDA Product Code

DTN

Device Class

Class II

Regulation

21 CFR Part 870.4400

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Sorin Blood Cardioplegia Console

  Class II

  FDA 510(k) K942582 Active Cleared 27 Jan 1995

• Venomidicard Pediatric Venous Reservoir with Integralcardiotomy Filter/Midicard Pediatric Cardiotomy Reservoir with Filt

  Class II

  FDA 510(k) K964907 Active Cleared 21 Aug 1997

• Code 150 Blood Component Collection Set and with Direct Draw Line

  Class II

  FDA 510(k) K963758 Active Cleared 20 Feb 1998

• Dideco Pediatric Arterial Filters

  Class II

  FDA 510(k) K945198 Active Cleared 27 Jun 1995

• Sorin Monolyth Venous Reservoir

  Class II

  FDA 510(k) K933481 Active Cleared 2 Nov 1993

• Sorin Bcd Advanced Pediatric Blood Cardioplegia Systems

  Class II

  FDA 510(k) K936183 Active Cleared 23 Mar 1994

See all devices from Sorin Biomedical, Inc. →

• What is the primary use of the Dideco Flexible Reservoir -- Product Designation 5063 in surgical settings?

  The Dideco Flexible Reservoir -- Product Designation 5063 is specifically designed for cardiopulmonary bypass procedures during open-heart surgeries. It serves as a collection and storage container for blood and other fluids, ensuring safe and efficient circulation management throughout the cardiac intervention.

• Is the Dideco Flexible Reservoir intended for single-use or repeated use in clinical environments?

  This device is explicitly intended for single-use in controlled clinical settings, such as operating rooms. Its flexible construction and design align with standards for cardiopulmonary support, making it unsuitable for reuse.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Dideco Flexible Reservoir received FDA 510K clearance under the Traditional 510(k) pathway, determined to be substantially equivalent to predicate devices. It is classified as a Class II medical device under FDA regulation 21 CFR 870.4400, reflecting its role in cardiopulmonary bypass procedures.

• Are there any specific volume or size variations available for this reservoir, and how is it typically supplied?

  While the exact volume specifications are not detailed in the provided data, the device’s flexible construction suggests it is engineered to accommodate varying volumes of blood and fluids during cardiopulmonary bypass. It is supplied as a sterile, single-use item, intended for immediate use in surgical settings without reprocessing.

• What type of advisory committee reviewed this device submission, and what was the focus of their evaluation?

  The submission for the Dideco Flexible Reservoir was reviewed by the FDA Cardiovascular (CV) Advisory Committee, which evaluates devices related to cardiovascular surgical procedures. The committee’s focus aligns with the device’s intended use in cardiovascular interventions, particularly those involving cardiopulmonary bypass.