NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE— 510(k) K071145
Substantially EquivalentNipro Medical Corporation
FDA 510(k) clearance K071145 for NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE, Substantially Equivalent on 2007-09-07. Applicant: Nipro Medical Corporation. Device class: 2.
Clearance details
- Applicant
- Nipro Medical Corporation
- Product code
- Code MPB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Miami, FL, US
Recent devices under product code MPB
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- K200426 — Acute Dual Lumen Hemodialysis Catheter
- K192807 — Duo-Flow Side x Side Double Lumen Catheter
- K192302 — Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
- K163458 — Zenysis Short-Term Dialysis Catheter
More clearances from Nipro Medical Corporation
view allAdverse events under product code MPB
product code MPB- Death
- 18
- Malfunction
- 1,042
- Total
- 1,060
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 K071145
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 K071145.
Data sourced from openFDA. This site is unofficial and independent of the FDA.