ClearanceBrief
Panels › Cardiovascular › Product code OES · Class 2

Cardiac Catheterization Kit

Regulation 870.1200

0510(k)s in 12 months (0 all time)
32recalls in 12 months (94 all time)
15recalls that name a 510(k)
Get daily alerts for OESSample briefCSV

Top companies in OES

DateFirm and productCodeLinked 510(k)
Oct 15, 2026Medline Industries, LP
1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N; 3) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit
Open, Classified
OESNone listed
Sep 16, 2026AVID Medical, Inc.
Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
Open, Classified
OESNone listed
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D.
Open, Classified
OESNone listed
Jul 31, 2026AVID Medical, Inc.
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15
Open, Classified
OESNone listed
Jul 31, 2026AVID Medical, Inc.
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05
Open, Classified
OESNone listed
Jul 27, 2026Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B
Open, Classified
OESNone listed
Jul 22, 2026AVID Medical, Inc.
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Open, Classified
OESNone listed
Jun 29, 2026Medline Industries, LP
Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 3) INTROFLEX 6F, 1L, TB, US, Model Number: STCV
Open, Classified
OESNone listed
Jun 26, 2026Medline Industries, LP
Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A
Open, Classified
OESNone listed
Jun 26, 2026Medline Industries, LP
Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B
Open, Classified
OESNone listed
Jun 25, 2026Medline Industries, LP
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRA
Open, Classified
OESNone listed
Jun 25, 2026Medline Industries, LP
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO CATH COMBINED PACK DYNJ43609S ANGIO PACK DYNJ67987D DYNJ80317A ANGIO SPECIAL PROCEDURE-LF DYNJ38412C ANGIOGRAM
Open, Classified
OESNone listed
Jun 17, 2026Medline Industries, LP
MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4)
Open, Classified
OESNone listed
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM
Open, Classified
OESNone listed
Jun 12, 2026Medline Industries, LP
Medline convenience kits: PORT A CATH DYNJ906818A
Open, Classified
OESNone listed
Jun 12, 2026Medline Industries, LP
MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276G
Open, Classified
OESNone listed
May 8, 2026Medline Industries, LP
1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 4. MTS,LEFT HEART,KIT, Medline K
Open, Classified
OESNone listed
May 7, 2026Medline Industries, LP
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DIAG/C
Open, Classified
OESNone listed
May 1, 2026AVID Medical, Inc.
Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
Open, Classified
OESNone listed
May 1, 2026AVID Medical, Inc.
Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
Open, Classified
OESNone listed
May 1, 2026AVID Medical, Inc.
Halyard CATH LAB kit. Model Number: SACL75AM.
Open, Classified
OESNone listed
May 1, 2026AVID Medical, Inc.
Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
Open, Classified
OESNone listed
May 1, 2026AVID Medical, Inc.
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
Open, Classified
OESNone listed
May 1, 2026AVID Medical, Inc.
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
Open, Classified
OESNone listed
Apr 30, 2026Medline Industries, LP
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEURO PACK-LF, Medline Kit Number/SKU DYNJ0578916X; 2. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ51
Open, Classified
OESNone listed
Apr 17, 2026Medline Industries, LP
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F DYNJ47665G ANGIO KIT PACK DYNJ83746 D
Open, Classified
OESNone listed
Apr 17, 2026Medline Industries, LP
Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CA
Open, Classified
OESNone listed
Apr 7, 2026Medline Industries, LP
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline S
Open, Classified
OESNone listed
Feb 17, 2026Medline Industries, LP
Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4A; 4) K
Open, Classified
OESNone listed
Feb 9, 2026Medline Industries, LP
Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109
Open, Classified
OESNone listed
Jan 28, 2026Medline Industries, LP
Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP RECOVERY PACK, Kit SKU DYNJT7034;
Open, Classified
OESNone listed
Nov 14, 2025Medline Industries, LP
MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A
Open, Classified
OESNone listed
Oct 16, 2025American Contract Systems Inc.
Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 9230
Open, Classified
OESNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A; 3) RADIOL ANGIO PACK-LF, Model Numbe
Open, Classified
OESNone listed
Mar 25, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number DYNJ69678; 3) ANGIOGRAPHY CV RAD PACK, Pack Number DYNJ64936A; 4) ANGIOGRAPHY
Open, Classified
OESNone listed
Mar 21, 2025American Contract Systems, Inc.
Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: No
Open, Classified
OESNone listed
Dec 30, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF DYN
Open, Classified
OESNone listed
Dec 20, 2024MEDLINE INDUSTRIES, LP - Northfield
MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.
Open, Classified
OESNone listed
Dec 5, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, REFDYNJ58409C; 4) GENDER AFFIRMING SURGERY, REFDYNJ66252A; 5) ST
Open, Classified
OESNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05
Open, Classified
OESNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03
Open, Classified
OESNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06
Open, Classified
OESNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05
Open, Classified
OESNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04
Open, Classified
OESNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05
Open, Classified
OESNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02
Open, Classified
OESNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15
Open, Classified
OESNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15
Open, Classified
OESNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03
Open, Classified
OESNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number: MSBM003-03
Open, Classified
OESNone listed

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.