NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
FDA 510(k) clearance K112628 · decided 2012-09-28
Clearance details
- K-number
- K112628
- Device name
- NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
- Applicant
- Nipro Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-09-09
- Decision date
- 2012-09-28
- Days to decision
- 385 days
- Clearance type
- Special
- Product code
- FJK
- Device class
- 2
- Regulation number
- 876.5820
- 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 SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Prim recall (Z-0624-2016) | Nipro Medical Corporation | 2016-01-08 |