ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER
FDA 510(k) clearance K102043 · decided 2010-11-18
Clearance details
- K-number
- K102043
- Device name
- ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER
- Applicant
- Rex Medical
- Decision
- Substantially Equivalent
- Date received
- 2010-07-20
- Decision date
- 2010-11-18
- Days to decision
- 121 days
- Clearance type
- Special
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 321 recall (Z-2696-2014) | Argon Medical Devices, Inc | 2014-09-24 |
| UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm) recall (Z-2697-2014) | Argon Medical Devices, Inc | 2014-09-24 |
| UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 c recall (Z-2698-2014) | Argon Medical Devices, Inc | 2014-09-24 |