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) |
|---|---|---|---|
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
ANCV78BC HEART PACK - 205947
HGCV05K CV SET UP PACK
MHPP97AR PACEMAKER PACK- 206010
UDBH37AW BASIC HEART PACK - 206044
UHPP82AH PERIPHERAL PACK - 209 Open, Classified |
OEZ | None listed |
| Oct 1, 2025 | Medline Industries, LP Medline Kits:
1) VALVE PACK-LF, Model Number: DYNJ0415366P;
2) VALVE PACK-LF, Model Number: DYNJ0415366Q Open, Classified |
OEZ | None listed |
| Aug 28, 2025 | American Contract Systems Inc AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC;
2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB;
3) OFF PUMP CABG Open, Classified |
OEZ | None listed |
| Aug 12, 2025 | Merit Medical Systems, Inc. Custom Manifold Kit:
REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B Open, Classified |
OEZ | None listed |
| Aug 4, 2025 | AVID Medical, Inc. HVI CARDIAC ROBOT PACK. Medical convenience kit. Open, Classified |
OEZ | None listed |
| Aug 4, 2025 | AVID Medical, Inc. CARDIAC ROBOT PACK. Medical convenience kit. Open, Classified |
OEZ | None listed |
| May 9, 2025 | AVID Medical, Inc. Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit. Open, Classified |
OEZ | None listed |
| May 9, 2025 | AVID Medical, Inc. Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit. Open, Classified |
OEZ | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D;
2) CARDIAC STERNAL PACK, Model Number: DYNJ32436A;
3) VEIN CLOSURE PACK, Model Number: DYN Open, Classified |
OEZ | None listed |
| Apr 4, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows:
CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, O Open, Classified |
OEZ | None listed |
| Mar 25, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) AV FISTULA PACK, Pack Number DYNJ80088;
2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J;
3) CABG, Pack Number DYNJ906462B;
4) CABG ACCESSORY PACK-LF, Pack Nu Open, Classified |
OEZ | None listed |
| Mar 21, 2025 | MEDLINE INDUSTRIES, LP - Northfield namic convenience kits labeled as:
1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468;
2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511;
3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST, REF 60020323;
4) M Open, Classified |
OEZ | None listed |
| Mar 14, 2025 | American Contract Systems Inc VEIN TRAY, Model No UTVT21C
UTVT21C02
UTVT21C-03 Open, Classified |
OEZ | None listed |
| Mar 14, 2025 | American Contract Systems Inc THORACIC PACK
, Model No UTTC82Y
UTTC82AA-01 Open, Classified |
OEZ | None listed |
| Mar 14, 2025 | American Contract Systems Inc OPEN HEART A PACK
, Model No UTOH19AI
UTOH19AJ-01
UTOH19AJ-02 Open, Classified |
OEZ | None listed |
| Mar 14, 2025 | American Contract Systems Inc MAJOR VASCULAR PACK
, Model No UTMV78X-01
UTMV78Y
UTMV78Y-01
UTMV78X-01
UTMV78Y-02 Open, Classified |
OEZ | None listed |
| Mar 14, 2025 | American Contract Systems Inc AV FISTULA
, Model No UTAV77T Open, Classified |
OEZ | None listed |
| Mar 14, 2025 | American Contract Systems Inc CV BASIC PUMP PACK
, Model No WECV23D Open, Classified |
OEZ | None listed |
| Mar 14, 2025 | American Contract Systems Inc OPEN HEART ADULT - SIDE A
, Model Nos LLOH01I-01
LLOH01I Open, Classified |
OEZ | None listed |
| Feb 10, 2025 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B;
2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D
3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA1 Open, Classified |
OEZ | None listed |
| Jan 15, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Fluid Delivery Set with Drip Chamber:
1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527;
2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNEDY HLTH, Item Number: 65111341;
3) MTO,ANGIO,SINGLE,SPI Open, Classified |
OEZ | None listed |
| Jan 15, 2025 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1;
2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3;
3 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM5;
4 ) ANEURYSM PACK , Cata Open, Classified |
OEZ | None listed |
| Dec 30, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline custom medical procedure kits labeled as:
1) OPEN HEART CDS-LF, REFCDS840451M;
2) NEURO PACK, REFDYNJ41516M;
3) RFD- AAA PACK, REFDYNJ54242B;
4) OPEN HEART A&B, REFDYNJ901203C;
5) OPEN H Open, Classified |
OEZ | None listed |
| Dec 20, 2024 | MEDLINE INDUSTRIES, LP - Northfield FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I.
Convenience kits used for various procedures.. Open, Classified |
OEZ | None listed |
| Dec 5, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE convenience kits labeled as:
1) MAJOR VASCULAR-LF, REF CDS840232L;
2) AVF-LF, REF CDS840233I;
3) GENERAL AAA #11-RF, REF CDS840261AB;
4) HEART CDS, REF CDS840387T;
5) OPEN HEART CDS PART Open, Classified |
OEZ | None listed |
| Nov 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and
(2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile. Open, Classified |
OEZ | None listed |
| Nov 22, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE procedure kits labeled as follows:
1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A;
2) CONT. 20G EPI MRI COMPATIBLE, REF PAIN1470A;
3) EPIDURAL CATHETERIZATION KIT, REF PAIN1644 Open, Classified |
OEZ | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard PACEMAKER PK - Medical convenience kits
Model Number: WKMC120-02 Open, Classified |
OEZ | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard PACEMAKER TRAY - Medical convenience kits
Model Number: VMPB0003-10 Open, Classified |
OEZ | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard ENDOVASCULAR - Medical convenience kits
Model Number: VMED008-02 Open, Classified |
OEZ | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard EP TRAY - Medical convenience kits
Model Number: VAST038-04 Open, Classified |
OEZ | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard IVR VASCULAR PACK - Medical convenience kits
Model Number: VAST027-08 Open, Classified |
OEZ | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard PACEMAKER DRAPE - Medical convenience kits
Model Number: VAST020-06 Open, Classified |
OEZ | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits
Model Number: VAPX040-01 Open, Classified |
OEZ | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard EP PACK - Medical convenience kits
Model Number: VANW018-06 Open, Classified |
OEZ | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard SAMMC-N PACEMAKER - Medical convenience kits
Model Number: SAMM065-10 Open, Classified |
OEZ | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits
Model Number: MMCC004-01 Open, Classified |
OEZ | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard PACEMAKER PACK - Medical convenience kits
Model Number: MAMC223-08 Open, Classified |
OEZ | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits
Model Number: ESJH017-03 Open, Classified |
OEZ | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard AORTA PACK - Medical convenience kits
Model Number: ESJH004-02 Open, Classified |
OEZ | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard OPEN HEART PACK MAIN - Medical convenience kits
Model Number: ESJH003-02 Open, Classified |
OEZ | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline brand, medical procedure convenience kits, labeled as:
a) CUH OPEN HEART A B C - CDS, REF CDS983202I;
a) PICC INSERTION KIT, REF DYNDC2486A;
a) OPEN HEART PACK, REF DYNJ01201L;
a) BREAST/ Open, Classified |
OEZ | None listed |
| Oct 17, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840 Open, Classified |
OEZ | None listed |
| Oct 17, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE KIT CV I II, REF DYNJ906071B Open, Classified |
OEZ | None listed |
| Oct 17, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE OPEN HEART, REF DYNJ904261B Open, Classified |
OEZ | None listed |
| Oct 17, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE OPEN HEART PACK, REF DYNJ66216C Open, Classified |
OEZ | None listed |
| Oct 17, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J Open, Classified |
OEZ | None listed |
| Sep 24, 2024 | American Contract Systems, Inc. Pacemaker, COPM11B; Medical convenience kit Open, Classified |
OEZ | None listed |
| Sep 24, 2024 | American Contract Systems, Inc. Paracentesis Thoracente, SLPT76H; Medical convenience kit Open, Classified |
OEZ | None listed |
| Sep 24, 2024 | American Contract Systems, Inc. Endovascular AAA Pack, ESED52B; Medical convenience kit Open, Classified |
OEZ | None listed |
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