Panels › Cardiovascular › Product code OES · Class 2
Cardiac Catheterization Kit
Regulation 870.1200
0510(k)s in 12 months (0 all time)
33recalls in 12 months (95 all time)
15recalls that name a 510(k)
Top companies in OES
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Nov 14, 2024 | AVID Medical, Inc. Halyard ANGIOGRAPHY PACK - Medical convenience kits
Model Number: MAMC218-18 Open, Classified |
OES | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard LINE INSERTION PACK - Medical convenience kits
Model Number: MAMC217-18 Open, Classified |
OES | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard IR BIOPSY PACK - Medical convenience kits
Model Number: AVMD019-01 Open, Classified |
OES | None listed |
| Nov 14, 2024 | AVID Medical, Inc. Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits
Model Number: AVMD018 Open, Classified |
OES | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline brand, medical procedure convenience kits, labeled as:
a) RADIOLOGY LP TRAY, REF DYNDH1609;
b) CARDIAC CATH PACK-LF, REF DYNJ19010I;
c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207;
d) ANGI Open, Classified |
OES | None listed |
| Sep 24, 2024 | American Contract Systems, Inc. Cath Lab Pack, CECL02P; Medical convenience kit Open, Classified |
OES | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedural kits labeled as:
1) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865;
2) CIRCUMCISION TRAY, Pack Number CIT6715;
3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095 Open, Classified |
OES | None listed |
| Aug 27, 2024 | MEDLINE INDUSTRIES, LP - Northfield See RES description Open, Classified |
OES | None listed |
| Aug 8, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ;
2) VASCULAR PACK , Pack Number CMPJ11455B ;
3) SALEM CATH LAB-LF , Pack Number DYNJ26938J ;
4) EH PEDIAT Open, Classified |
OES | None listed |
| Jul 10, 2024 | Cardinal Health 200, LLC Presource kits and trays, labeled as:
1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB;
2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10;
3) Cardiac Catheterization Kit, Catalog Open, Classified |
OES | None listed |
| Jun 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Sterile surgical convenience kits:
a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
b. Me Open, Classified |
OES | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE Kits, trays, and packs labeled as follows:
a) CATH LAB CDS, REF CDS840228F;
b) PEDIATRIC PORT A CATH TRAY, REF DYNDC2128B;
c) PK, RADIOLOGY, REF DYNJ44087A;
d) PORT ACCESS PACK-LF, REF DY Open, Classified |
OES | None listed |
| Jan 26, 2024 | American Contract Systems, Inc. Custom procedural convenience kits and trays, cardiac, labeled as:
a) HEART CATHETERIZATION TRAY, kit number JRHC45G;
b) TAVR PACK, kit number LLTV10;
c) CATH PED LF SJH, kit number SJCA21F;
d) C Open, Classified |
OES | None listed |
| Oct 26, 2023 | American Contract Systems, Inc. Sub Q Recorder Pack, REF BPRC87A Open, Classified |
OES | 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. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475;
b. MULTI-LUMEN CVC INSERTION BUN Open, Classified |
OES | 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. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C;
b. CRMC TUNNE Open, Classified |
OES | 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. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A;
b. 16CM 3L 7FR CVC INSERT Open, Classified |
OES | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320;
b) CENTRAL VENOUS CATH INSERTION BUNDLE PI, M Open, Classified |
OES | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83105;
b) TESIO, Model Number DYNJ83251;
c) ANGIOGRAPHY PACK-LF, Model Number DY Open, Classified |
OES | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C;
b) CATH LAB PACK, Model Number DYNJ55455A;
c) CATH LAB 2, Model N Open, Classified |
OES | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model Number 00-400305R;
b) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C;
c) ANG Open, Classified |
OES | None listed |
| Apr 25, 2023 | ROi CPS LLC Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath. Open, Classified |
OES | None listed |
| Feb 10, 2023 | MEDLINE INDUSTRIES, LP - Northfield Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD Open, Classified |
OES | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following:
a. CARDIAC CATH PACK-LF;
b. ANGIOGRAPHY-NS-LF;
c. EP BASIC SET UP PACK;
d. IMPLANT PACK-LF;
e. PORT PACEMAKER INSERTION PACK;
f. OPEN H Open, Classified |
OES | None listed |
| Jun 16, 2022 | American Contract Systems, Inc. Various Angiography/Cath Lab packs/trays Open, Classified |
OES | None listed |
| Mar 22, 2022 | American Contract Systems, Inc. ACS Cath Lab Pack Open, Classified |
OES | None listed |
| Apr 13, 2020 | American Contract Systems Sterile Custom Packs to be used in surgical procedures. Terminated |
OES | None listed |
| Feb 18, 2020 | Avid Medical, Inc. Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers. Terminated |
OES | None listed |
| Apr 24, 2019 | Centurion Medical Products Corporation TRIPLE LUMEN CVC 20CM BUNDLE
STCVC2040 Terminated |
OES | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation VANTEX 7FR, 16CM, 3L CVC BUNDLE
ECVC6670 Terminated |
OES | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation OR VANTEX 7FR 3L 16CM CVC
ECVC6665 Terminated |
OES | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation CENTRAL LINE BUNDLE 16CM MULTIMED
ECVC6545A Terminated |
OES | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation CENTRAL LINE BUNDLE 16CM MULTIMED
ECVC6545 Terminated |
OES | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation CENTRAL LINE BUNDLE
ECVC6375 Terminated |
OES | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation CVC INSERTION BUNDLE 8.5FR 4L 16CM
ECVC6355 Terminated |
OES | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation CVC TRIPLE LUMEN SAFETY BUNDLE
ECVC6070 Terminated |
OES | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation CVC BUNDLE VANTEX 7F, 3L, 20CM
ECVC6065 Terminated |
OES | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation CVC BUNDLE MULTIMED, 3L, 20CM
ECVC6060 Terminated |
OES | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation CVC BUNDLE, 20CM, 3L, PI
ECVC5120A Terminated |
OES | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation CVC BUNDLE, 20CM, 3L, PI
ECVC5120 Terminated |
OES | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation CVC BUNDLE, 20CM, 4L, PI
ECVC5095 Terminated |
OES | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation CENTRAL VENOUS ACCESS DEVICE BUNDLE
ECVC2840 Terminated |
OES | K171957 |
| Apr 24, 2019 | Centurion Medical Products Corporation TRIPLE LUMEN BUNDLE KIT
ECVC1540 Terminated |
OES | K171957 |
| Oct 26, 2018 | Merit Medical Systems, Inc. Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580 Terminated |
OES | None listed |
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