KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY— 510(k) K060339
Substantially EquivalentTyco Healthcare/Kendall
FDA 510(k) clearance K060339 for KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY, Substantially Equivalent on 2006-04-28. Applicant: Tyco Healthcare/Kendall. Device class: 2.
Clearance details
- Applicant
- Tyco Healthcare/Kendall
- Product code
- Code NGT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mansfield, MA, US
Recent devices under product code NGT
view all- K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe
- K233623 — Praxiject SP 0.9% NaCl
- K231724 — Flush Syringe (Prefilled 0.9% normal saline solution)
- K231363 — Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
- K223584 — Pre-Filled Normal Saline Flush Syringe
More clearances from Tyco Healthcare/Kendall
view allAdverse events under product code NGT
product code NGT- Death
- 12
- Malfunction
- 2,008
- Other
- 4
- Total
- 2,024
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 K060339
K-number listed on FDA's recall record- Z-2525-2015 — Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
- Z-2526-2015 — Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135137 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
- Z-2527-2015 — Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135139 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
- Z-2528-2015 — Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm Item Code: 8888211424 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
- Z-2529-2015 — Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety Components, 13.5 Fr x 20 cm Item Code: 8888213420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
- Z-2530-2015 — Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code:8888221420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
- Z-2531-2015 — Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 16 cm Item Code: 8888222416 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
- Z-2533-2015 — Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 13 cm Item Code: 8888233413 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
- Z-2534-2015 — Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm Item Code: 8888233420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
- Z-2535-2015 — MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
- Z-2536-2015 — MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Item Code: 8888103003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060339.
Data sourced from openFDA. This site is unofficial and independent of the FDA.