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NC TREK™ RX Coronary Dilatation Catheter +6 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K180040
Identifiers
- 510(k) Number
- K180040 FDA 510(k)
- FDA Product Code
- LOX FDA 510(k)
- Models / Variants
- NC TREK™ RX Coronary Dilatation Catheter FDA 510(k)NC TREK™ OTW Coronary Dilatation Catheter FDA 510(k)TREK™ RX Coronary Dilatation Catheter FDA 510(k)TREK™ OTW Coronary Dilatation Catheter FDA 510(k)MINI TREK™ RX Coronary Dilatation Catheter FDA 510(k)MINI TREK™ OTW Coronary Dilatation Catheter FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5100 FDA 510(k)
- Regulation Number
- 870.5100 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
NC TREK™ RX Coronary Dilatation Catheter +6 more models by Abbott Vascular — Class II — FDA_510K — listed in FDA 510(k) — 7 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180040 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Vascular
Sources (1)
- FDA 510(k) K180040 24 fields · synced Jun 18, 2026