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BD INTROSYTE PRECISION INTRODUCER - Bd Introsyte Autoguard Shielded Introducer
FDA 510(k)Class II (US FDA 510(k))
510(k) K020834
Identifiers
- 510(k) Number
- K020834 FDA 510(k)
- FDA Product Code
- DYB FDA 510(k)
- Models / Variants
- Bd Introsyte Precision Introducer FDA 510(k)Bd Introsyte-N Precision Introducer FDA 510(k)Bd Introsyte Autoguard Shielded Introducer FDA 510(k)Bd I FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1340 FDA 510(k)
- Regulation Number
- 870.1340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
BD INTROSYTE PRECISION INTRODUCER - Bd Introsyte Autoguard Shielded Introducer by Becton Dickinson Infusion Therapy Systems Inc. — Class II — FDA_510K…
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 | K020834 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton Dickinson Infusion Therapy Systems Inc.
- FDA Applicant
- Becton Dickinson Infusion Therapy Systems, Inc.
Sources (1)
- FDA 510(k) K020834 24 fields · synced Jun 18, 2026