Panels › Cardiovascular › Product code OEZ · Class 2
Cardiovascular Procedure Kit
Regulation 870.1200
0510(k)s in 12 months (0 all time)
50recalls in 12 months (232 all time)
4recalls that name a 510(k)
Top companies in OEZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749601308341, REF/Catalog No. 60130834, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits are intended Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601113111, REF/Catalog No. 60111311, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog No. 601001815, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenie Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog No. 600801020, STERILE, Rx ONLY ---For single use only. ---Device Listing Number D136588.
Product Usage:
NAMIC Convenienc Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits ar Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496007057101, REF/Catalog No. 600705710, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kit Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART, UPN H7496006044121, REF/Catalog No. 600604412, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits are Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H7496005216131, REF/Catalog No. 600521613, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits are intended Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 600500113, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Ki Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, MOBILE CATH LAB KIT, UPN H749600419211, REF/Catalog No. 60041921, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, 3 VALVE MANIFOLD KIT, UPN H749600411611, REF/Catalog No. 60041161, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenien Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600407061, REF/Catalog No. 60040706, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, 3 VALVE KIT CARDIOVASCULAR PROCEDURE KIT, UPN H749600403131, REF/Catalog No. 60040313, STERILE, Rx ONLY --- --- For single use only. --- Device Listing Number D136588.
Product Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749600329421, REF/Catalog No. 60032942, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits are intended to Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 60030935, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kit Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749600203741, REF/Catalog No. 60020374, STERILE, Rx ONLY --- For single use only. Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits are intended to be Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, NEURO ANGIO KIT, UPN H749600202361, REF/Catalog No. 60020236, STERILE, Rx ONLY --- For single use only. Device Listing Number D136683.
Product Usage:
NAMIC Convenience Kits a Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, 5 VALVE MANIFOLD KIT, UPN H749600105121, REF/Catalog No. 60010512, STERILE, Rx ONLY --- For single use only. Device Listing Number D136588.
Product Usage:
NAMIC Convenience Ki Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496001001111, REF/Catalog No. 600100111, STERILE, Rx ONLY For single use only. ---Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits ar Terminated |
OEZ | None listed |
| Oct 31, 2014 | Terumo Cardiovascular Systems Corp Terumo Custom Cardiovascular and Perfusion Procedure Kits
Catalog Codes: Kits with a 5-digit code beginning with the digit 6:
Catalog Number: 6XXXX ;
Catalog Codes: Kits with a 5-digit code beginnin Terminated |
OEZ | None listed |
| Apr 16, 2014 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE
Catalog Number: 73431 Terminated |
OEZ | None listed |
| Jan 19, 2012 | Navilyst Medical, Inc NAMIC (TM) Convenience Kit --- Legal Manufacturer Navilyst Medical, Inc, 26 Forest St, Marlborough, MA 01752 USA --- Made in USA: 10 Glen Falls Technical Park, Glen Falls, NY 12801 USA --- each unit l Terminated |
OEZ | None listed |
| Jan 29, 2010 | Merit Medical Systems, Inc. Jeanes Hospital Custom Cath Procedure Tray, K09T-08945A, Sterile EO, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095.
Intended for fluid management convenience when cat Terminated |
OEZ | None listed |
| Jan 29, 2010 | Merit Medical Systems, Inc. Jeanes Hospital Custom Cath Procedure Tray, K09T-08945, Sterile EO, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095.
Intended for fluid management convenience when cath Terminated |
OEZ | None listed |
| Jan 29, 2010 | Merit Medical Systems, Inc. Custom Angiographic Kit, K09-MS3084, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Intended for fluid management convenience. Terminated |
OEZ | None listed |
| Jan 29, 2010 | Merit Medical Systems, Inc. Custom Cardiac Cath Pack Kit, K09-08945, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Intended for fluid management convenience when catheterization is required. Terminated |
OEZ | None listed |
| Jan 29, 2010 | Merit Medical Systems, Inc. University Health System Custom Cardiac Cath Pack, K09T-02178, Srterile EO, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095.
Intended for fluid management convenience w Terminated |
OEZ | None listed |
| Mar 28, 2008 | Terumo Cardiovascular Systems Corp Cardiovascular Procedure Kit, P/N 70579-04, St. Louis University Hospital Pump & Table Pack, Terumo Cardiovascular, Ashland, MA. (the Pump & Table pack contains a weighted flexible sucker, Catalog No. Terminated |
OEZ | K982891 |
| Mar 28, 2008 | Terumo Cardiovascular Systems Corp Cardiovascular Procedure Kit, P/N 70295-02, St. Louis University Hospital Pump & Table Pack, Terumo Cardiovascular, Ashland, MA. ( Pump & table pack contains a weighted flexible sucker, Catalog No. Terminated |
OEZ | K982891 |
| Mar 28, 2008 | Terumo Cardiovascular Systems Corp Cardiovascular Procedure Kit, P/N 64789-01, Wisconsin Cardiovascular Services Pump and Table Pack, Terumo Cardiovascular, Ashland, MA. (the Pump & table pack contains a weighted flexible sucker, Catal Terminated |
OEZ | K982891 |
| Mar 28, 2008 | Terumo Cardiovascular Systems Corp Cardiovascular Procedure Kit, P/N: 70932-01, HCSG-St. Mary's Hospital, Richmond, VA , X-coated Pump and Table Pack, Terumo Cardiovascular, Ashland, MA (the X-coated pump and table pack contains a weig Terminated |
OEZ | K982891 |
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