Identifiers
- 510(k) Number
- K193322 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 NovaCross CTO Microcatheter is a cardiovascular device intended to facilitate the intraluminal placement of conventional and other devices during percutaneous interventions. It is designed for use in chronic total occlusion (CTO) treatment, supporting navigation through complex vascular lesions.
Supplied by Nitiloop, Ltd., the device received FDA 510(k) clearance (K193322) on April 2, 2020, following a traditional review process. It is substantially equivalent to a predicate device and is indicated for use in cardiovascular procedures as part of the NovaCross family of microcatheters.
Frequently asked questions
What is the NovaCross CTO Microcatheter used for?
The NovaCross CTO Microcatheter is intended to facilitate the intraluminal placement of conventional and other devices during percutaneous interventions, specifically designed for use in chronic total occlusion (CTO) treatment to support navigation through complex vascular lesions.
How is the NovaCross CTO Microcatheter supplied and by whom?
The NovaCross CTO Microcatheter is supplied by Nitiloop, Ltd., located at 1st Tidar St., Pardes Hanna, Israel, with postal code 3701000, as indicated in the device authorization records.
What regulatory clearance does the NovaCross CTO Microcatheter have?
The NovaCross CTO Microcatheter received FDA 510(k) clearance under submission K193322 on April 2, 2020, following a traditional review process and was determined to be substantially equivalent to a predicate device.
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: Microbot Medical Acquires Nitiloop's NovaCross Family of Microcatheters, NovaCross CTO Microcatheter (K193322) - FDA 510 (k), PDF Nitiloop Ltd. ℅ Wanda Carpinella VP Regulatory Affairs Boston ..., Microbot Medical acquires FDA-approved devices of Nitiloop
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193322 | Class II | Active |
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Manufacturer
- Manufacturer
- Nitiloop , Ltd.
Sources (1)
- FDA 510(k) K193322 24 fields · synced Sep 25, 2026