Bigboss Mantatay Catheter Mantaray Guidewires
510(k) K120533
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120533 | Date22 May 2012 | 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- Withdrawn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
- Full name
- Bigboss Catheters Mantatay Catheter Mantaray Guidewires
- 510(k) Number
- FDA Product Code
- PDU
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Bigboss Mantatay Catheter Mantaray Guidewires are Catheters for Crossing Total Occlusions, designed as over-the-wire, dual-lumen, percutaneous devices. These catheters provide support and steering for guidewires via a central lumen or sideports, facilitating navigation through complex vascular obstructions. Their radiopaque markers enhance visibility under fluoroscopy, ensuring precise placement during interventional procedures.
Supplied as single-use, disposable devices, these catheters are intended for use in cardiovascular interventions within a sterile setting. They are classified under FDA regulation 870.1250 and hold a FDA 510(k) clearance (K120533) with a Substantially Equivalent determination. The product code is PDU, and the devices are manufactured by Bridgepoint Medical. No third-party reprocessing is indicated, and MRI safety data is not specified in the regulatory submission.
Other devices from Bridgepoint Medical
Questions
AI-generated answers, 20 Sep 2026
What types of vascular obstructions are these catheters specifically designed to help navigate through during procedures?
The Bigboss Mantatay Catheter Mantaray Guidewires are designed as over-the-wire, dual-lumen catheters for crossing total occlusions—meaning they are intended for navigating through completely blocked blood vessels. Their dual-lumen design and radiopaque markers provide support and steering for guidewires, improving precision during complex interventional procedures like angioplasty or stent placement.
Are these catheters reusable, or are they meant to be used only once?
These catheters are single-use, disposable devices, as explicitly stated in the product description. They are intended for use in a sterile setting and are not designed for reprocessing or reuse. This aligns with standard practices for percutaneous cardiovascular devices to ensure patient safety and sterility.
How do I know if the catheter is properly positioned during a procedure?
The catheters include radiopaque markers, which enhance visibility under fluoroscopy. This feature allows clinicians to track the catheter’s position in real-time during the procedure, ensuring precise placement within the vascular system. The markers help confirm accurate navigation through obstructions.
What storage conditions should I follow for these catheters before use?
While the provided data does not specify exact storage conditions, the catheters are sterile, single-use devices intended for percutaneous use. They should be stored in a clean, dry environment, protected from contamination, and used within the manufacturer’s recommended shelf life. Always follow the included packaging instructions for optimal preservation.