510(k) K061497 ยท NZW Heparin, Vascular Access Flush
SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML
| Applicant | Excelsior Medical Corp., Neptune NJ, US |
| Decision | Substantially Equivalent, Feb 23, 2007 |
| Received | May 31, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061497
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2012 | Vygon Corporation 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 lumens Terminated |
NZW | None listed |
| Jun 13, 2012 | Vygon Corporation 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 l Terminated |
NZW | None listed |
| Jun 13, 2012 | Vygon Corporation 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 l Terminated |
NZW | None listed |
| Jun 13, 2012 | Vygon Corporation 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 Terminated |
NZW | None listed |
| Jun 13, 2012 | Vygon Corporation 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 Terminated |
NZW | None listed |
| Jun 13, 2012 | Vygon Corporation 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 lumens Terminated |
NZW | None listed |
| Jun 13, 2012 | Vygon Corporation Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit
Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Terminated |
NZW | None listed |
| Jun 13, 2012 | Vygon Corporation 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 lumens Terminated |
NZW | None listed |
| Jun 13, 2012 | Vygon Corporation Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit
Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Terminated |
NZW | None listed |
| Jun 13, 2012 | Vygon Corporation Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit
Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Terminated |
NZW | None listed |
| Jun 13, 2012 | Vygon Corporation Churchill Medical Systems, Inc. DRESSING CHANGE KIT
Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Terminated |
NZW | None listed |
| Jun 13, 2012 | Vygon Corporation 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 lumens Terminated |
NZW | None listed |
| Jun 5, 2012 | Excelsior Medical Corp Heparin Lock Flush Solution 100 Unit/mL, USP
3 ml, 4 ml, 5mL, 6 ml fill in a 10 ml Flush Syringe ZR
Excelsior Medical Neptune, NJ 07753
(800) 487-4276
Made in USA
NDC 63807060055.
Used to maintain Terminated |
NZW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.