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Hemosplit Xk, Hemosplit Xk Catheter, 16fr X 42 Cm, Kit +1 more model
FDA 510(k)Class II (US FDA 510(k))
510(k) K033294
Identifiers
- 510(k) Number
- K033294 FDA 510(k)
- FDA Product Code
- MSD FDA 510(k)
- Models / Variants
- 16fr X 19 Cm, Kit With Microintroducer FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5540 FDA 510(k)
- Regulation Number
- 876.5540 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESK Substantially Equivalent — Kit FDA 510(k)
Hemosplit Xk, Hemosplit Xk Catheter, 16fr X 42 Cm, Kit +1 more model by C. R. Bard, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 2 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 | K033294 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K033294 24 fields · synced Jun 18, 2026