40 cc Grande
510(k) K974247
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974247 | Date10 Feb 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DSP
- FDA applicant
- Boston Scientific Corp
- Device class
- Class II
- Regulation
- 21 CFR Part 870.3535
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The 40 cc Grande is an intra-aortic balloon system designed for mechanical circulatory support. It features a polyurethane-coated nylon shaft with a symmetrical polyurethane balloon at the distal end, coated with a thin layer of silicone fluid for lubricity and performance. The device is intended for temporary hemodynamic augmentation in patients with acute cardiac conditions.
This device is supplied as a single-use, sterile system and is regulated under FDA 510(k) clearance (K974247) as a Class II medical device (product code DSP). It is intended for use in controlled clinical settings, such as cardiac catheterization labs, and requires proper storage under manufacturer-recommended conditions to maintain sterility and functionality. The system includes a central lumen for inflation/deflation control and is compatible with standard intra-aortic balloon pump protocols.
Other devices from Boston Scientific
Questions
AI-generated answers, 19 Sep 2026
What clinical scenarios is the 40 cc Grande intra-aortic balloon system primarily used for?
The 40 cc Grande is designed for temporary hemodynamic augmentation in patients experiencing acute cardiac conditions, such as severe heart failure or cardiogenic shock, where mechanical circulatory support is required to stabilize the patient’s circulation. It is intended for use in controlled settings like cardiac catheterization labs to assist with short-term cardiac function during critical interventions.
Is the 40 cc Grande system single-use or reusable, and how does this affect its handling?
The 40 cc Grande is explicitly labeled as a single-use device, meaning it is intended for one-time use only. This design ensures sterility and safety, as reuse could compromise integrity and introduce infection risks. After use, the system must be discarded, and a new sterile unit must be prepared for subsequent procedures.
What storage conditions are required to maintain the device’s sterility and functionality?
The manufacturer recommends storing the 40 cc Grande under controlled conditions to preserve sterility and functionality. While specific details like temperature or humidity aren’t provided, standard sterile medical device storage practices—such as keeping it in its original packaging, away from direct sunlight or extreme temperatures—should be followed. Always refer to the included instructions for precise storage guidelines.
What materials is the 40 cc Grande constructed from, and how does this impact its performance?
The device features a polyurethane-coated nylon shaft with a symmetrical polyurethane balloon at the distal end. The balloon is further coated with a thin layer of silicone fluid to enhance lubricity and performance during inflation/deflation cycles. These materials contribute to durability, flexibility, and compatibility with standard intra-aortic balloon pump protocols, ensuring reliable hemodynamic support.
How is the 40 cc Grande’s inflation/deflation controlled, and what compatibility considerations should clinicians keep in mind?
The system includes a central lumen specifically designed for inflation and deflation control, allowing precise regulation of the balloon’s cycle. It is engineered to be compatible with standard intra-aortic balloon pump protocols, meaning it can integrate seamlessly with existing clinical systems. Clinicians should verify compatibility with their specific pump equipment before use to ensure optimal performance and safety.