NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET— 510(k) K112628
Substantially EquivalentNipro Medical Corporation
FDA 510(k) clearance K112628 for NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, Substantially Equivalent on 2012-09-28. Applicant: Nipro Medical Corporation. Device class: 2.
Clearance details
- Applicant
- Nipro Medical Corporation
- Product code
- Code FJK
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Miami, FL, US
Recent devices under product code FJK
view allMore clearances from Nipro Medical Corporation
view allAdverse events under product code FJK
product code FJK- Death
- 52
- Malfunction
- 3,430
- Total
- 3,482
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K112628
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112628.
Data sourced from openFDA. This site is unofficial and independent of the FDA.