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Swan-Ganz Pacing Probe and Catheters +4 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K233983
Identifiers
- 510(k) Number
- K233983 FDA 510(k)
- FDA Product Code
- DYG FDA 510(k)
- Models / Variants
- Swan-Ganz Pacing Probe and Catheters FDA 510(k)Swan-Ganz Bipolar Pacing Catheter (D97120F5) FDA 510(k)Swan-Ganz Bipolar Pacing Catheter (D97130F5) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1240 FDA 510(k)
- Regulation Number
- 870.1240 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Swan-Ganz Pacing Probe and Catheters +4 more models by Edwards Lifesciences — Class II — FDA_510K — listed in FDA 510(k) — 5 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 | K233983 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences
Sources (1)
- FDA 510(k) K233983 24 fields · synced Jun 18, 2026