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) |
|---|---|---|---|
| Jun 16, 2022 | American Contract Systems, Inc. Various Pacemaker Packs, Cardio Thoracic Packs Open, Classified |
OEZ | None listed |
| Jun 6, 2022 | MEDLINE INDUSTRIES, LP - SPT Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS, Model Number DYNJ902880K, d. OPEN HEART A & B, Mo Open, Classified |
OEZ | None listed |
| Mar 21, 2022 | ROi CPS LLC Regard brand CABG Pack A and B - Spartanburg Terminated |
OEZ | None listed |
| Feb 3, 2022 | Terumo Cardiovascular Systems Corp Cardiovascular Procedure Kit catalog # 76645 & 73806 Terminated |
OEZ | None listed |
| Oct 27, 2021 | Medline Industries Inc Bedside PICC CDS Convenience Kit Terminated |
OEZ | None listed |
| Jun 4, 2021 | Avid Medical, Inc. FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03 Terminated |
OEZ | None listed |
| Mar 4, 2021 | ROi CPS LLC Regard, Item Number 830067009, custom cardiovascular procedure kit Open, Classified |
OEZ | None listed |
| Nov 13, 2020 | Medline Industries Inc Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries. Terminated |
OEZ | None listed |
| Feb 18, 2020 | Avid Medical, Inc. Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers. Terminated |
OEZ | None listed |
| Dec 20, 2018 | Terumo Cardiovascular Systems Corporation Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE)
Catalog Number: 140222 Terminated |
OEZ | None listed |
| Dec 18, 2017 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters.
The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard Leukocyte Reduc Terminated |
OEZ | None listed |
| May 12, 2017 | Terumo Cardiovascular Systems Corp Tubing Pack Convenience Kit, Product Code 65217
Product Usage:
Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it. Terminated |
OEZ | None listed |
| Jul 25, 2016 | Terumo Cardiovascular Systems Corp Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows:
This product is intended for use only in the extracorporeal circuit for the cardiopulm Terminated |
OEZ | None listed |
| Apr 7, 2016 | AngioDynamics Inc. NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF
Catalog No. 601319810, UPN Product No. H7496013198101
Product Usage - This needle is intended to be placed over the guidewire to enlarge t Terminated |
OEZ | None listed |
| Apr 7, 2016 | AngioDynamics Inc. NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941
Product Usage - This needle is intended to be placed over the guidewire to enlarg Terminated |
OEZ | None listed |
| Apr 7, 2016 | AngioDynamics Inc. NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box of 30 pieces, box label contains UPN Product No. H965652300291 Terminated |
OEZ | None listed |
| Apr 7, 2016 | AngioDynamics Inc. NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111
Product Usage - This needle is intended to be placed over the guidewire to enlarg Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H965PK193168S1, REF/Catalog No. PK193168S, STERILE, Rx ONLY ---For single use only. Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Fluid Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART, POTENTIAL REVISION TO 600604412, UPN H965PK0604436S1, REF/Catalog No. PK0604436S, STERILE, Rx ONLY - For single use only. --- Device Listing Number D136588
NAMIC C Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Flui Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H965601955411, REF/Catalog No. 60195541, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Flui Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H965601931651, REF/Catalog No. 60193165, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Flui Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, PTCA KIT, UPN H9656019110161, REF/Catalog No. 601911016, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, 3V WMMII KIT, UPN H965601852521, REF/Catalog No. 60185252, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to b Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Flui Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H965601017731, REF/Catalog No. 60101773, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to b Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, 3V MANIFOLD KIT, UPN H965601011621, REF/Catalog No. 60101162, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600416321, REF/Catalog No. 60041632, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended t Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H965600338021, REF/Catalog No. 60033802, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Fluid Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H9656002072121, REF/Catalog No. 600207212, STERILE, Rx ONLY --- For single use only. ---Device Listing Number D136588.
NAMIC Convenience Kits are intended Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600125911, REF/Catalog No. 60012591, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749606204751, REF/Catalog No. 60620475, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Flui Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602322341, REF/Catalog No. 60232234, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended t Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Flui Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602207461, REF/Catalog No. 60220746, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749602001451, REF/Catalog No. 60200145, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Fluid Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602000571, REF/Catalog No. 60200057, STERILE, Rx ONLY --- For single use only.
--- Device Listing Number D136588.
NAMIC Convenience Kits are intended t Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749601907851, REF/Catalog No. 60190785, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Fluid Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749601904231, REF/Catalog No. 60190423, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Flui Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601900431, REF/Catalog No. 60190043, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, HOPKINS LEFT HEART, UPN H749601836621, REF/Catalog No. 60183662, STERILE, Rx ONLY ---- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intend Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749601827221, REF/Catalog No. 60182722, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Flui Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749601801561, REF/Catalog No. 60180156, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Fluid Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 60161793, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601605351, REF/Catalog No. 60160535, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended t Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H7496016046121, REF/Catalog No. 601604612, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits are intended t Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601506721, REF/Catalog No. 60150672, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits a Terminated |
OEZ | None listed |
| Feb 26, 2015 | Navilyst Medical, Inc NAMIC Convenience Kit, UPN H749601399921, REF/Catalog No. 60139992, 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, UPN H7496013148131, REF/Catalog No. 601314813, 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, UPN H749601314811, REF/Catalog No. 60131481, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits are intended to Terminated |
OEZ | None listed |
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