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Bardex I.c.plus Foley Catheter With Silver Salts In Hydrogel Coating (3cc Ballo…
FDA 510(k)Class II (US FDA 510(k))
510(k) K002612
Identifiers
- 510(k) Number
- K002612 FDA 510(k)
- FDA Product Code
- EZL FDA 510(k)
- Models / Variants
- 3cc Balloon: 17008 FDA 510(k)170010 FDA 510(k)5cc Balloon FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5130 FDA 510(k)
- Regulation Number
- 876.5130 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Bardex I.c.plus Foley Catheter With Silver Salts In Hydrogel Coating (3cc Ballo… by C. R. Bard, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 3 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 | K002612 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K002612 24 fields · synced Jun 18, 2026