TaperSeal Intra-Aortic Balloon Catheter & Introducer Kit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K962177 FDA 510(k)
- FDA Product Code
- DSP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3535 FDA 510(k)
- Regulation Number
- 870.3535 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TaperSeal Intra-Aortic Balloon Catheter & Introducer Kit is a System, Balloon, Intra-Aortic And Control designed for mechanical circulatory support. It consists of an intra-aortic balloon catheter and an introducer system intended to assist cardiac function by augmenting coronary and systemic perfusion during periods of reduced cardiac output, such as in acute myocardial infarction or cardiogenic shock. The device operates via inflation and deflation of the balloon within the aorta, timed to the cardiac cycle to improve hemodynamics.
This kit is supplied sterile and intended for single-use. It includes multiple sizes of intra-aortic balloon catheters (e.g., IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20) and an introducer sheath for percutaneous insertion. The device is classified as Class II under FDA regulations (21 CFR 870.3535) and was granted FDA 510(k) clearance under the Traditional pathway by the Cardiovascular Advisory Committee. Storage and handling must comply with sterile medical device protocols, and compatibility with MRI environments is not specified.
Frequently asked questions
What is the TaperSeal Intra-Aortic Balloon Catheter & Introducer Kit used for?
This kit is designed for mechanical circulatory support to assist cardiac function. It works by inflating and deflating an intra-aortic balloon within the aorta, timed to the cardiac cycle, which improves coronary and systemic perfusion during periods of reduced cardiac output. This is particularly useful in conditions like acute myocardial infarction or cardiogenic shock where the heart’s pumping ability is compromised.
How is the TaperSeal Intra-Aortic Balloon Catheter & Introducer Kit supplied, and is it sterile?
The kit is supplied sterile and intended for single-use only. It includes multiple sizes of intra-aortic balloon catheters (e.g., IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20) along with an introducer sheath for percutaneous insertion. Sterility ensures safety for one-time clinical use without risk of cross-contamination.
What sizes of intra-aortic balloon catheters are available in this kit?
The kit offers several sizes of intra-aortic balloon catheters, including IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20. These variations allow clinicians to select the appropriate catheter length and diameter based on patient anatomy and clinical needs, ensuring optimal placement and performance.
How should the TaperSeal Intra-Aortic Balloon Catheter & Introducer Kit be stored?
Since this is a sterile medical device, storage must comply with standard sterile medical device protocols. It should be kept in a clean, dry environment, protected from contamination, and away from direct sunlight or extreme temperatures. Follow manufacturer guidelines for packaging integrity to maintain sterility until use.
Is the TaperSeal Intra-Aortic Balloon Catheter & Introducer Kit compatible with MRI environments?
The device data does not specify compatibility with MRI environments. If MRI imaging is required for a patient using this device, consult the manufacturer’s instructions or clinical guidelines to ensure safety, as some components may contain materials or features that could interact with magnetic fields.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT by C.R ..., Bard Taperseal Intra-aortic Balloon Catheter & Introducer Kit (K962177 ..., BARD TAPERSEAL INTRA-AORTI… — K962177 · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K962177 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K962177 24 fields · synced Oct 1, 2026