VAXCEL PLUS CHRONIC DIALYSIS CATHETER
FDA 510(k) clearance K040736 · decided 2004-05-18
Clearance details
- K-number
- K040736
- Device name
- VAXCEL PLUS CHRONIC DIALYSIS CATHETER
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2004-03-22
- Decision date
- 2004-05-18
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/37/Metal Catalog Number : 45-552 recall (Z-1499-05) | Boston Scientific Corporation | 2005-09-02 |
| Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/37/Plastic Catalog Number : 45-55 recall (Z-1500-05) | Boston Scientific Corporation | 2005-09-02 |
| Vaxcel Plus Chronic Dialysis Catheters -Kit/CPU/15/37/Metal Catalog Number: 45-554 recall (Z-1501-05) | Boston Scientific Corporation | 2005-09-02 |
| Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/37/Plastic Catalog Number: 45-555 recall (Z-1502-05) | Boston Scientific Corporation | 2005-09-02 |
| Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/50/Metal Catalog Number: 45-556 recall (Z-1503-05) | Boston Scientific Corporation | 2005-09-02 |