VAXCEL PORT, MODELS 45-336 AND 45-338
FDA 510(k) clearance K032375 · decided 2003-08-19
Clearance details
- K-number
- K032375
- Device name
- VAXCEL PORT, MODELS 45-336 AND 45-338
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2003-08-01
- Decision date
- 2003-08-19
- Days to decision
- 18 days
- Clearance type
- Special
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Glens Falls, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vaxcel Plastic Low Profile Port (non-valved) chest port, with 6Fr Polyurethane Catheter, C recall (Z-0944-05) | Boston Scientific Corporation | 2005-06-30 |
| Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Silicone Catheter, Catalog #4 recall (Z-0945-05) | Boston Scientific Corporation | 2005-06-30 |
| Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Polyurethane Catheter, Catalo recall (Z-0946-05) | Boston Scientific Corporation | 2005-06-30 |