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Bd Introsyte Precision Introducer, Bd Introsyte Autogaurd Shielded Introducer
FDA 510(k)Class I (US FDA 510(k))
510(k) K013304
Identifiers
- 510(k) Number
- K013304 FDA 510(k)
- FDA Product Code
- DBY FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5520 FDA 510(k)
- Regulation Number
- 866.5520 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Bd Introsyte Precision Introducer, Bd Introsyte Autogaurd Shielded Introducer by Becton Dickinson Infusion Therapy Systems Inc. — Class I — FDA_510K — listed…
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 | K013304 | Class I | 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) K013304 24 fields · synced Jun 18, 2026