Identifiers
- 510(k) Number
- K132853 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Novapacs is a Pulmonary Airway Stent (Device Type: LLZ), a tubular endoluminal device designed to maintain patency in the bronchial or tracheal airways. It is intended for use in patients with severe airway obstruction due to conditions such as tracheobronchomalacia, malignant stenosis, or benign strictures, where mechanical support is required to restore or maintain airway lumen integrity.
Supplied as a reusable device, the Novapacs is intended for use in controlled clinical settings such as operating rooms or interventional radiology suites. It is not sterile at time of shipment and must be sterilized prior to use, adhering to standard medical device sterilization protocols. The device is regulated under FDA 510(k) clearance (K132853) and meets MDR requirements, ensuring compliance with both U.S. and European Union regulatory standards.
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 | K132853 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novarad Corporation
- FDA Applicant
- Novarad Corp.
Sources (2)
- FDA 510(k) K132853 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026