ClearanceBrief
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)
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Top companies in OEZ

DateFirm and productCodeLinked 510(k)
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Feb 26, 2015Navilyst 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
OEZNone listed
Oct 31, 2014Terumo 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
OEZNone listed
Apr 16, 2014Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
Terminated
OEZNone listed
Jan 19, 2012Navilyst 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
OEZNone listed
Jan 29, 2010Merit 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
OEZNone listed
Jan 29, 2010Merit 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
OEZNone listed
Jan 29, 2010Merit Medical Systems, Inc.
Custom Angiographic Kit, K09-MS3084, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for fluid management convenience.
Terminated
OEZNone listed
Jan 29, 2010Merit 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
OEZNone listed
Jan 29, 2010Merit 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
OEZNone listed
Mar 28, 2008Terumo 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
OEZK982891
Mar 28, 2008Terumo 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
OEZK982891
Mar 28, 2008Terumo 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
OEZK982891
Mar 28, 2008Terumo 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
OEZK982891

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