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)
Oct 16, 2025American 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
OEZNone listed
Oct 1, 2025Medline Industries, LP
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
Open, Classified
OEZNone listed
Aug 28, 2025American 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
OEZNone listed
Aug 12, 2025Merit 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
OEZNone listed
Aug 4, 2025AVID Medical, Inc.
HVI CARDIAC ROBOT PACK. Medical convenience kit.
Open, Classified
OEZNone listed
Aug 4, 2025AVID Medical, Inc.
CARDIAC ROBOT PACK. Medical convenience kit.
Open, Classified
OEZNone listed
May 9, 2025AVID Medical, Inc.
Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
Open, Classified
OEZNone listed
May 9, 2025AVID Medical, Inc.
Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
Open, Classified
OEZNone listed
Apr 17, 2025MEDLINE 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
OEZNone listed
Apr 4, 2025MEDLINE 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
OEZNone listed
Mar 25, 2025MEDLINE 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
OEZNone listed
Mar 21, 2025MEDLINE 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
OEZNone listed
Mar 14, 2025American Contract Systems Inc
VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
Open, Classified
OEZNone listed
Mar 14, 2025American Contract Systems Inc
THORACIC PACK , Model No UTTC82Y UTTC82AA-01
Open, Classified
OEZNone listed
Mar 14, 2025American Contract Systems Inc
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
Open, Classified
OEZNone listed
Mar 14, 2025American Contract Systems Inc
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
Open, Classified
OEZNone listed
Mar 14, 2025American Contract Systems Inc
AV FISTULA , Model No UTAV77T
Open, Classified
OEZNone listed
Mar 14, 2025American Contract Systems Inc
CV BASIC PUMP PACK , Model No WECV23D
Open, Classified
OEZNone listed
Mar 14, 2025American Contract Systems Inc
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
Open, Classified
OEZNone listed
Feb 10, 2025Cardinal 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
OEZNone listed
Jan 15, 2025MEDLINE 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
OEZNone listed
Jan 15, 2025Cardinal 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
OEZNone listed
Dec 30, 2024MEDLINE 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
OEZNone listed
Dec 20, 2024MEDLINE INDUSTRIES, LP - Northfield
FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
Open, Classified
OEZNone listed
Dec 5, 2024MEDLINE 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
OEZNone listed
Nov 25, 2024MEDLINE 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
OEZNone listed
Nov 22, 2024MEDLINE 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
OEZNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02
Open, Classified
OEZNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10
Open, Classified
OEZNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02
Open, Classified
OEZNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04
Open, Classified
OEZNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08
Open, Classified
OEZNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06
Open, Classified
OEZNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: VAPX040-01
Open, Classified
OEZNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard EP PACK - Medical convenience kits Model Number: VANW018-06
Open, Classified
OEZNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10
Open, Classified
OEZNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01
Open, Classified
OEZNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08
Open, Classified
OEZNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03
Open, Classified
OEZNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02
Open, Classified
OEZNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02
Open, Classified
OEZNone listed
Oct 23, 2024MEDLINE 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
OEZNone listed
Oct 17, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840
Open, Classified
OEZNone listed
Oct 17, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE KIT CV I II, REF DYNJ906071B
Open, Classified
OEZNone listed
Oct 17, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE OPEN HEART, REF DYNJ904261B
Open, Classified
OEZNone listed
Oct 17, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE OPEN HEART PACK, REF DYNJ66216C
Open, Classified
OEZNone listed
Oct 17, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J
Open, Classified
OEZNone listed
Sep 24, 2024American Contract Systems, Inc.
Pacemaker, COPM11B; Medical convenience kit
Open, Classified
OEZNone listed
Sep 24, 2024American Contract Systems, Inc.
Paracentesis Thoracente, SLPT76H; Medical convenience kit
Open, Classified
OEZNone listed
Sep 24, 2024American Contract Systems, Inc.
Endovascular AAA Pack, ESED52B; Medical convenience kit
Open, Classified
OEZNone listed

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