Panels › Cardiovascular › Product code OEQ · Class 2
Angiography/Angioplasty Kit
Regulation 870.1650
0510(k)s in 12 months (0 all time)
18recalls in 12 months (90 all time)
6recalls that name a 510(k)
Top companies in OEQ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D Open, Classified |
OEQ | None listed |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461 Open, Classified |
OEQ | None listed |
| Jun 25, 2026 | Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.
ANGIO PACK
DYNJ30565C
DYNJ32555B
ANGIO PACK-LF
DYNJ0774765U
ANGIO TRAY
DYNJ46153A
ANGIOGRAM TRAY
DYNJ336 Open, Classified |
OEQ | None listed |
| Jun 25, 2026 | Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.
ANGIOGRAM PACK-LF
DYNJ21574J
JUDKINS PACK
DYNJ51126 Open, Classified |
OEQ | None listed |
| Jun 17, 2026 | Medline Industries, LP MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit Number/SKU DYNJ37378A Open, Classified |
OEQ | None listed |
| May 8, 2026 | Medline Industries, LP Medline medical convenience kits, containing Namic Manifold, Labeled as:
1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C;
2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185;
3. ANGIO KIT, Open, Classified |
OEQ | None listed |
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) ANGIO PROCEDURE PACK, Model Number:00-401824AA;
2) ENDO KIT W/SYRINGE, Model Number:DYKE1743;
3) BGMC ANGIOGRAPHY PACK-LF, Model Number:DYNJ0800934D;
4) GENERAL ENDO PA Open, Classified |
OEQ | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/SKU DYNJ0774765U Open, Classified |
OEQ | None listed |
| Apr 29, 2026 | Merit Medical Systems, Inc. Philips Bridge Prep Kit
REF: K12-09098C
Sterile EO, Rx ONLY Open, Classified |
OEQ | None listed |
| Apr 29, 2026 | Merit Medical Systems, Inc. Philips Bridge Prep Kit
REF: K12-09098C
Sterile EO, Rx ONLY Open, Classified |
OEQ | None listed |
| Apr 29, 2026 | Merit Medical Systems, Inc. Philips Bridge Prep Kit
REF: K12-09098B
Sterile EO, Rx ONLY Open, Classified |
OEQ | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
JUDKINS PACK DYNJ51126
ANGIO PACK DYNJ32555C, DYNJ66631
ANGIO TRAY DYNJ46153B
ANGIOGRAPHY PACK DYNJ26855F Open, Classified |
OEQ | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Kits:
1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M;
2) ANGIO PACK, Model Number: DYNJT2021G;
3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B;
4) ANGIO PACK, Model Number: DYNJ51279;
5) A Open, Classified |
OEQ | None listed |
| Apr 7, 2026 | Medline Industries, LP Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows:
1. CATH LAB PACK-LF, Medline SKU 00-HCT055P;
2. INTER Open, Classified |
OEQ | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) ENDO KIT W/SYRINGE, Model Number: DYKE1743;
2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D;
3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J;
4) OR ANGIO PA Open, Classified |
OEQ | None listed |
| Jan 16, 2026 | Merit Medical Systems, Inc. Allwell Angioplasty Pack
REF: IS-30-B1/B Open, Classified |
OEQ | None listed |
| Jan 16, 2026 | Merit Medical Systems, Inc. Merit Medical , Custom Procedure Kit
Reference Numbers: K12T-04270A K12T-07956 K12T-10922B Open, Classified |
OEQ | None listed |
| Jan 16, 2026 | Merit Medical Systems, Inc. Allwell Inflation Device, for angiographic use
REF: IS-30-A Open, Classified |
OEQ | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
HSAN63N ANGIO PACK
IHAN02W ANGIOGRAPHY PACK
MHCA98AK CORONARY ANGIO PACK- 205991
RCAN45C ANGIO CUSTOM RCH
UDCO10F CVL CORONARY PACK 219224 Open, Classified |
OEQ | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1;
2) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ05350V;
3) ANGIOGRAPHY PACK, Model Number: DYNJ3 Open, Classified |
OEQ | None listed |
| Mar 25, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) ANGIO PACK, Pack Number DYNJ50624A;
2) ANGIO PACK, Pack Number DYNJ30501F;
3) ANGIO PACK-LF, Pack Number DYNJ0954970G;
4) ANGIOGRAPHY 6 FRENCH PACK, Pack Num Open, Classified |
OEQ | None listed |
| Mar 21, 2025 | MEDLINE INDUSTRIES, LP - Northfield namic convenience kits labeled as:
MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710 Open, Classified |
OEQ | None listed |
| Mar 14, 2025 | American Contract Systems Inc GENERAL ANGIO PACK
, Model Nos
LLAP75G
LLAP75G-01
LLAP75G-02
LLAP75G-03 Open, Classified |
OEQ | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A;
b) ANGIOGRAM WRO-LF, REF DYNJ41876B Open, Classified |
OEQ | None listed |
| Oct 11, 2024 | Merit Medical Systems, Inc. Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-0 Open, Classified |
OEQ | None listed |
| Sep 24, 2024 | American Contract Systems, Inc. IR Procedure Pack, CEAT19W; Medical convenience kit Open, Classified |
OEQ | None listed |
| Sep 20, 2024 | Merit Medical Systems, Inc. Custom Procedure Kit, REF: K12T-11077 Open, Classified |
OEQ | None listed |
| Sep 17, 2024 | ROi CPS LLC regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009 Open, Classified |
OEQ | None listed |
| Aug 27, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure packs containing Shenli syringes, labeled as follows:
1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ;
2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG;
3) ANGIOGRAPHY DRAPE P Open, Classified |
OEQ | None listed |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K05-02166B K05T-00380C K05T Open, Classified |
OEQ | None listed |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
Custom Procedure Kit (Angiography/Angioplasty kit), REF:
OPT0242-00
S1279-01
S2953
S2 Open, Classified |
OEQ | None listed |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
K22C (Vein Tray Angiography kit), REF:
K09T-11796F
K12T-01558G
K12T-01558H
K12T-01822 Open, Classified |
OEQ | None listed |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
K12T/12PI (Custom Pressure Monitoring Kit), REF:
K12-03846
K12-04185A
K12-03447
K12M- Open, Classified |
OEQ | None listed |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
K04 (Custom Syringe Kit), REF:
K05-00203M
K05-00511J
K05-00547J
K05-00612Q
K05-00819A Open, Classified |
OEQ | None listed |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
K02 (Custom Syringe Kit), REF:
K02-00873A,
Inject fluids into, or withdraw fluids fr Open, Classified |
OEQ | None listed |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
Custom Procedure Kit (Angiography/angioplasty kit), REF:
K12T-10773
K12T-09284D
K12T- Open, Classified |
OEQ | None listed |
| Aug 7, 2024 | American Contract Systems, Inc. American Contract Systems Special Procedure Pack convenience kit Open, Classified |
OEQ | None listed |
| Jul 10, 2024 | Cardinal Health 200, LLC Presource kits and trays, labeled as:
1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605;
2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606;
3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607;
4) ANGIOGRAPH Open, Classified |
OEQ | None listed |
| Aug 3, 2023 | MEDLINE INDUSTRIES, LP - Northfield Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following:
a. ANGIO, Model Number: DYNJ902507B;
b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DY Open, Classified |
OEQ | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-401318M;
b) ANGIOGRAPHY OR, Model Number CDS984944C;
c) ANGIOG Open, Classified |
OEQ | None listed |
| Jul 3, 2023 | DeRoyal Industries Inc Custom medical procedure packs labeled as:
a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102;
b) CHOLANGIOGRAPHY KIT, REF 89-7322;
c) CATH LAB PACK, REF 89-9183 Open, Classified |
OEQ | None listed |
| Feb 10, 2023 | MEDLINE INDUSTRIES, LP - Northfield Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN, Reorder Number DYNDC2691 Open, Classified |
OEQ | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield FEMORAL ARTERY PACK-LF. Sterile Procedural Tray Open, Classified |
OEQ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Angio Pack, Item No.686-199, Open, Classified |
OEQ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142, Open, Classified |
OEQ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Angioplasty, Item No.682-1937, Open, Classified |
OEQ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930 Open, Classified |
OEQ | None listed |
| Jun 16, 2022 | American Contract Systems, Inc. Various Angiography packs/trays Open, Classified |
OEQ | None listed |
| Feb 11, 2021 | Cardinal Health 200, LLC JUDKINS PACK Terminated |
OEQ | None listed |
| Nov 10, 2020 | Merit Medical Systems, Inc. Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105
For Angiography/angioplasty.
The contents of the kit are surgical drapes, gowns, towe Terminated |
OEQ | None listed |
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