Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter System-Jugular/Subcl…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093659 FDA 510(k)
- FDA Product Code
- DTK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3375 FDA 510(k)
- Regulation Number
- 870.3375 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Eclipse Filter System is an intravascular cardiovascular filter designed for the prevention of recurrent pulmonary embolism. It is intended for permanent placement in the vena cava in patients where anticoagulants are contraindicated.
This system includes a delivery device preloaded with the filter, along with a 10 French introducer catheter and dilator set. The device is regulated as a Class II medical device under FDA 510(k) clearance K093659.
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: Eclipse Filter System-femoral Delivery Kit, Eclipse Filter System ..., Eclipse Filter System-femoral and Jugular/Subclavian Delivery Kits ..., Eclipse Filter System-femoral Delivery Kit, Eclipse Filter System ..., Eclipse Filter System-femoral Delivery Kit, Eclipse Filter System ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093659 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K093659 24 fields · synced Sep 24, 2026