Blood Pump Model 7000

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K780942 ↗

FDA Product Code

DWB

Device Class

Class II

Regulation

21 CFR Part 870.4370

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from 3M Health Care, Sarns →

• What is the Blood Pump Model 7000 used for?

  The Blood Pump Model 7000 is designed specifically for cardiopulmonary bypass procedures during open-heart surgeries. It circulates blood through an extracorporeal circuit, maintaining oxygenation and systemic perfusion while the heart is temporarily bypassed. This ensures stable blood flow and supports critical cardiac interventions by providing controlled, regulated movement of blood via its roller-type mechanism.

• Is the Blood Pump Model 7000 single-use or reusable?

  The Blood Pump Model 7000 is a reusable medical instrument. It is intended for use in sterile operating room environments, requiring adherence to medical device sterilization protocols to maintain patient safety and device integrity between procedures.

• What regulatory approval does the Blood Pump Model 7000 hold?

  The Blood Pump Model 7000 has received FDA 510(k) clearance (K780942) under the product code DWB, classified as substantially equivalent to a predicate device. It falls under Class II – Special Controls for cardiovascular applications, ensuring compliance with strict manufacturing and performance standards.

• How should the Blood Pump Model 7000 be stored?

  Storage and handling of the Blood Pump Model 7000 must comply with medical device sterilization protocols to preserve sterility and functionality. Since it is reusable, it should be stored in a clean, dry environment and processed according to manufacturer guidelines to prevent contamination and ensure readiness for subsequent use in sterile operating room conditions.

• What type of mechanism does the Blood Pump Model 7000 use?

  The Blood Pump Model 7000 employs a roller-type mechanism to facilitate controlled and regulated blood flow during cardiopulmonary bypass. This design helps maintain consistent perfusion and oxygenation of the patient’s blood while the heart is temporarily bypassed during surgery.