SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML— 510(k) K061497

Clearance details

Applicant

Excelsior Medical Corp.

Product code

Code NZW

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2006-05-31

Decision date

2007-02-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Neptune, NJ, US

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• Z-1797-2012 — Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box Prefilled syringes are used to maintain the patency of indwelling catheter lumensClass II·Terminated·Vygon Corporation·20120511
• Z-1798-2012 — Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumensClass II·Terminated·Vygon Corporation·20120511
• Z-1799-2012 — Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumensClass II·Terminated·Vygon Corporation·20120511
• Z-1800-2012 — Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumensClass II·Terminated·Vygon Corporation·20120511
• Z-1801-2012 — Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumensClass II·Terminated·Vygon Corporation·20120511
• Z-1802-2012 — Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumensClass II·Terminated·Vygon Corporation·20120511
• Z-1803-2012 — Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumensClass II·Terminated·Vygon Corporation·20120511
• Z-1804-2012 — Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumensClass II·Terminated·Vygon Corporation·20120511
• Z-1805-2012 — Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumensClass II·Terminated·Vygon Corporation·20120511
• Z-1806-2012 — Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumensClass II·Terminated·Vygon Corporation·20120511
• Z-1807-2012 — Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumensClass II·Terminated·Vygon Corporation·20120511
• Z-1808-2012 — Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumensClass II·Terminated·Vygon Corporation·20120511

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061497.