speX LP Support Catheter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200094 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 speX LP Support Catheter is a vascular catheter designed to provide mechanical support within coronary arteries during percutaneous coronary interventions. It is intended for use as an adjunct to guidewires and balloons, helping to maintain vessel patency and reduce the risk of dissection or occlusion during procedures.
This device is supplied sterile and intended for single-use. It is classified under product code DQY and has received FDA 510(k) clearance under a Special 510(k) review, with a decision date of March 18, 2020. The catheter is intended for use in interventional cardiology settings and must be handled according to sterile medical device protocols. No MRI safety information is specified.
Frequently asked questions
What is the speX LP Support Catheter primarily used for during coronary procedures?
The speX LP Support Catheter is designed to provide mechanical support within coronary arteries during percutaneous coronary interventions (PCI). It works alongside guidewires and balloons to help maintain vessel patency, reducing risks like dissection or occlusion during the procedure. This makes it useful in interventional cardiology settings where stability and protection of the artery are critical.
Is the speX LP Support Catheter reusable, or is it meant for single-use only?
The speX LP Support Catheter is explicitly intended for single-use only. This aligns with standard sterile medical device protocols, ensuring patient safety and preventing cross-contamination between procedures.
How is the speX LP Support Catheter supplied, and what sterility precautions should be taken?
The speX LP Support Catheter is supplied sterile, meaning it is pre-sterilized and packaged to maintain sterility until use. Since it is single-use, it must be handled according to sterile medical device protocols to avoid contamination before and during the procedure.
What type of regulatory review did the speX LP Support Catheter undergo, and what does that mean for its use?
The speX LP Support Catheter underwent a Special 510(k) review by the FDA, which is a streamlined process for devices deemed substantially equivalent to a predicate device. This review was conducted under the Cardiovascular (CV) Advisory Committee, and the device received clearance on March 18, 2020. The clearance indicates it meets FDA standards for safety and effectiveness as an adjunct to guidewires and balloons in coronary interventions.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K200094 | Class II | Active |
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Manufacturer
- Manufacturer
- Reflow Medical, Inc.
- FDA Applicant
- Reflow Medical
Sources (2)
- FDA 510(k) K200094 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 1, 2026