DURASPAN HEMODIALYSIS LONG-TERM CATHETER
FDA 510(k) clearance K100169 · decided 2010-02-18
Clearance details
- K-number
- K100169
- Device name
- DURASPAN HEMODIALYSIS LONG-TERM CATHETER
- Applicant
- R4 Vascular, Inc.
- Decision
- Unknown
- Date received
- 2010-01-20
- Decision date
- 2010-02-18
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO, Manufactured for recall (Z-2412-2011) | R4 Vascular Inc | 2011-06-06 |