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)
Top companies in OES
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Medline 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 |
OES | None listed |
| Sep 16, 2026 | AVID Medical, Inc. Haylard UNIV IMAGING BIOPSY TRUCUSTOM;
Model/Item Number (Kit): VARV042-03; Open, Classified |
OES | None listed |
| Aug 26, 2026 | Medline Industries, LP Medline convenience kits labeled as:
1) FEMORAL PACK, Medline Kit SKU DYNJ909393A;
2) FEVAR, Medline Kit SKU DYNJ910295D. Open, Classified |
OES | None listed |
| Jul 31, 2026 | AVID Medical, Inc. Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds.
SAMMC ANGIOGRAPHY
SAMM066-15 Open, Classified |
OES | None listed |
| Jul 31, 2026 | AVID Medical, Inc. Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds.
CARDIAC CATH PACK EAMC1000-05 Open, Classified |
OES | None listed |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B Open, Classified |
OES | None listed |
| Jul 22, 2026 | AVID Medical, Inc. Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01.
Convenience kit. Open, Classified |
OES | None listed |
| Jun 29, 2026 | Medline 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 |
OES | None listed |
| Jun 26, 2026 | Medline Industries, LP Medline Convenience kits containing recalled Swan-Ganz Catheters
RIGHT HEART CATH PACK CTX
DYNJ68530A Open, Classified |
OES | None listed |
| Jun 26, 2026 | Medline Industries, LP Medline Convenience kits containing recalled Swan-Ganz Catheters
RIGHT HEART CATH PACK CTX
DYNJ68530B Open, Classified |
OES | None listed |
| Jun 25, 2026 | Medline 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 |
OES | None listed |
| Jun 25, 2026 | Medline 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 |
OES | None listed |
| Jun 17, 2026 | Medline 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 |
OES | None listed |
| Jun 13, 2026 | ARROW 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 |
OES | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
PORT A CATH
DYNJ906818A Open, Classified |
OES | None listed |
| Jun 12, 2026 | Medline Industries, LP MINOR CATH LAB PACK
DYNJ84775A
OR VASCULAR ANGIO PACK
DYNJ47269D
PORT-A-CATH
DYNJ63276G Open, Classified |
OES | None listed |
| May 8, 2026 | Medline 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 |
OES | None listed |
| May 7, 2026 | Medline 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 |
OES | None listed |
| May 1, 2026 | AVID Medical, Inc. Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029. Open, Classified |
OES | None listed |
| May 1, 2026 | AVID Medical, Inc. Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15. Open, Classified |
OES | None listed |
| May 1, 2026 | AVID Medical, Inc. Halyard CATH LAB kit. Model Number: SACL75AM. Open, Classified |
OES | None listed |
| May 1, 2026 | AVID Medical, Inc. Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05. Open, Classified |
OES | None listed |
| May 1, 2026 | AVID Medical, Inc. Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36. Open, Classified |
OES | None listed |
| May 1, 2026 | AVID Medical, Inc. Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02. Open, Classified |
OES | None listed |
| Apr 30, 2026 | Medline 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 |
OES | None listed |
| Apr 17, 2026 | Medline 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 |
OES | None listed |
| Apr 17, 2026 | Medline 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 |
OES | None listed |
| Apr 7, 2026 | Medline 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 |
OES | None listed |
| Feb 17, 2026 | Medline 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 |
OES | None listed |
| Feb 9, 2026 | Medline Industries, LP Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109 Open, Classified |
OES | None listed |
| Jan 28, 2026 | Medline 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 |
OES | None listed |
| Nov 14, 2025 | Medline Industries, LP MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A Open, Classified |
OES | None listed |
| Oct 16, 2025 | American 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 |
OES | None listed |
| Apr 17, 2025 | MEDLINE 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 |
OES | None listed |
| Mar 25, 2025 | MEDLINE 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 |
OES | None listed |
| Mar 21, 2025 | American 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 |
OES | None listed |
| Dec 30, 2024 | MEDLINE 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 |
OES | None listed |
| Dec 20, 2024 | MEDLINE INDUSTRIES, LP - Northfield MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures. Open, Classified |
OES | None listed |
| Dec 5, 2024 | MEDLINE 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 |
OES | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard ANGIO PACK - Medical convenience kits
Model Number: WRNM047-05 Open, Classified |
OES | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard MANIFOLD CATH PACK - Medical convenience kits
Model Number: VMED005-03 Open, Classified |
OES | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits
Model Number: VMCC021-06 Open, Classified |
OES | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard ANGIO TRAY - Medical convenience kits
Model Number: VAPX021-05 Open, Classified |
OES | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard RAD PACK - Medical convenience kits
Model Number: VANW017-04 Open, Classified |
OES | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard CATH LAB PACK - Medical convenience kits
Model Number: VANW016-05 Open, Classified |
OES | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard CPT CARDIAC CATH PACK - Medical convenience kits
Model Number: SHAN430-02 Open, Classified |
OES | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard SAMMC ANGIOGRAPHY - Medical convenience kits
Model Number: SAMM066-15 Open, Classified |
OES | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard OR ENDOVASCULAR TRAY - Medical convenience kits
Model Number: SAMM048-15 Open, Classified |
OES | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard INTERVENTIONAL TRAY - Medical convenience kits
Model Number: PSSC004-03 Open, Classified |
OES | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits
Model Number: MSBM003-03 Open, Classified |
OES | None listed |
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