Identity
- Trade Name
- SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM FDA PMA
- Generic Name
- DEVICE, ANGIOPLASTY, LASER, CORONARY FDA PMA
Identifiers
- PMA Number
- P910001 FDA PMA
- FDA Product Code
- LPC FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The ECLA GlideLight Catheter is a laser angioplasty device designed for use in percutaneous transluminal coronary procedures. It is indicated for the treatment of atherosclerotic and/or calcified lesions in coronary arteries, including occluded saphenous vein bypass grafts, ostial lesions, long lesions greater than 20 mm, moderately calcified stenoses, total occlusions traversable by a guidewire, and lesions previously failed by balloon angioplasty.
This device is supplied as part of the Spectranetics CVX-300 Excimer Laser System and is intended for use in clinical settings by trained physicians. It is a single-use device requiring sterile handling and is not MRI safe unless explicitly stated. The catheter must be stored according to manufacturer specifications and used only under the conditions outlined in its PMA approval (P910001).
Frequently asked questions
What is the ECLA GlideLight Catheter used for?
The ECLA GlideLight Catheter is used for laser angioplasty in patients with single or multivessel coronary artery disease. It treats lesions composed of atherosclerotic plaque and/or calcified material that are traversable by a guidewire, including occluded saphenous vein bypass grafts, ostial lesions, long lesions (>20 mm), moderately calcified stenoses, total occlusions, and lesions previously failed by balloon angioplasty.
Is the ECLA GlideLight Catheter reusable?
No, the ECLA GlideLight Catheter is a single-use device. It is supplied sterile and intended for one-time use only during a percutaneous coronary intervention procedure. Reuse is not permitted and could compromise patient safety and device performance.
What system is the ECLA GlideLight Catheter part of?
The ECLA GlideLight Catheter is a component of the Spectranetics CVX-300 Excimer Laser System. It is specifically designed to work with this laser system to deliver laser energy for coronary artery revascularization procedures as outlined in its PMA approval.
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 (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P910001 | Class III | Active |
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Manufacturer
- Manufacturer
- Spectranetics Corp.
Sources (1)
- FDA PMA P910001 24 fields · synced Sep 18, 2026