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HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit - HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204)
FDA 510(k)Class II (US FDA 510(k))
510(k) K243941
Identifiers
- 510(k) Number
- K243941 FDA 510(k)
- FDA Product Code
- LJS FDA 510(k)
- Models / Variants
- HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5970 FDA 510(k)
- Regulation Number
- 880.5970 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit - HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204) by…
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 | K243941 | Class II | Active |
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Manufacturer
- Manufacturer
- Access Vascular, Inc
- FDA Applicant
- Access Vascular, Inc.
Sources (1)
- FDA 510(k) K243941 24 fields · synced Jun 19, 2026