NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE
FDA 510(k) clearance K071145 · decided 2007-09-07
Clearance details
- K-number
- K071145
- Device name
- NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE
- Applicant
- Nipro Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2007-04-24
- Decision date
- 2007-09-07
- Days to decision
- 136 days
- Clearance type
- Abbreviated
- Product code
- MPB
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access devic recall (Z-0161-2016) | Nipro Medical Corporation | 2015-10-23 |