Ballast 088 Long Sheath
FDA 510(k)Class II (US FDA 510(k))
by Balt Usa Llc
Identifiers
- 510(k) Number
- K182918 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ballast 088 Long Sheath is a braid-reinforced catheter designed for the introduction of interventional devices into peripheral, coronary, and neuro vasculature. It features a single lumen and a radiopaque distal tip to enhance visibility under fluoroscopy, ensuring precise placement during procedures. The variable stiffness design provides controlled flexibility and pushability, accommodating diverse clinical applications. This device is classified under product code DQY and is intended for use in vascular interventions requiring sheath support.
The Ballast 088 Long Sheath is supplied as a single-use device and is intended for sterile use in clinical settings. It is not MRI-safe and must be handled according to standard aseptic techniques. The sheath is available in a fixed length and diameter as specified in the product code. Regulatory authorizations include FDA 510(k) clearance under the Traditional pathway, with the submission reviewed by the Cardiovascular Advisory Committee. Compliance with the Medical Device Directive (MDD 93/42/EEC) is also noted in the documentation.
Frequently asked questions
What is the Ballast 088 Long Sheath designed for?
The Ballast 088 Long Sheath is specifically engineered for introducing interventional devices into peripheral, coronary, and neuro vasculature. Its braid-reinforced construction and single lumen design provide stability and support during procedures, while the radiopaque distal tip ensures clear visibility under fluoroscopy for accurate placement. This makes it ideal for vascular interventions requiring sheath support, such as angioplasty or stent delivery.
How is the Ballast 088 Long Sheath supplied and intended for use?
The Ballast 088 Long Sheath is supplied as a single-use, sterile device. It is intended exclusively for clinical use in controlled environments where aseptic techniques are followed. Due to its single-use nature, it must not be reused or reprocessed, and proper handling protocols must be adhered to throughout the procedure to maintain sterility and patient safety.
Is the Ballast 088 Long Sheath MRI-safe?
No, the Ballast 088 Long Sheath is not MRI-safe. This means it should not be used in or near an MRI machine, as the magnetic fields could cause damage to the device or pose a risk to the patient. Always verify compatibility with imaging modalities before use, and consult manufacturer guidelines if MRI procedures are anticipated.
What are the key specifications of the Ballast 088 Long Sheath?
The Ballast 088 Long Sheath features a fixed length and diameter as defined by its product code (DQY). Its variable stiffness design provides controlled flexibility and pushability, balancing maneuverability with structural support. The radiopaque distal tip enhances visibility during fluoroscopy-guided procedures, ensuring precise navigation through vascular pathways. The device is classified under product code DQY for vascular interventions.
How should the Ballast 088 Long Sheath be stored?
The Ballast 088 Long Sheath should be stored in its original, sealed packaging to preserve sterility. It must be kept in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. Always check the expiration date on the packaging before use, and follow the manufacturer’s storage instructions to ensure optimal performance and safety.
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: Ballast - Balt Group, PDF ballast, PDF Ballast™ 088 Long Sheath Instructions for Use
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182918 | Class II | Active |
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Manufacturer
- Manufacturer
- Balt Usa Llc
- FDA Applicant
- Balt USA, LLC
Sources (1)
- FDA 510(k) K182918 24 fields · synced Oct 1, 2026