ClearanceBrief
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)
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Top companies in OES

DateFirm and productCodeLinked 510(k)
Nov 14, 2024AVID Medical, Inc.
Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number: MSBM003-03
Open, Classified
OESNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18
Open, Classified
OESNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-18
Open, Classified
OESNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01
Open, Classified
OESNone listed
Nov 14, 2024AVID Medical, Inc.
Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018
Open, Classified
OESNone listed
Oct 23, 2024MEDLINE 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
OESNone listed
Sep 24, 2024American Contract Systems, Inc.
Cath Lab Pack, CECL02P; Medical convenience kit
Open, Classified
OESNone listed
Aug 28, 2024MEDLINE 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
OESNone listed
Aug 27, 2024MEDLINE INDUSTRIES, LP - Northfield
See RES description
Open, Classified
OESNone listed
Aug 8, 2024MEDLINE 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
OESNone listed
Jul 10, 2024Cardinal 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
OESNone listed
Jun 28, 2024MEDLINE 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
OESNone listed
Feb 25, 2024MEDLINE 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
OESNone listed
Jan 26, 2024American 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
OESNone listed
Oct 26, 2023American Contract Systems, Inc.
Sub Q Recorder Pack, REF BPRC87A
Open, Classified
OESNone listed
Aug 3, 2023MEDLINE 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
OESNone listed
Aug 3, 2023MEDLINE 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
OESNone listed
Aug 3, 2023MEDLINE 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
OESNone listed
Jul 20, 2023MEDLINE 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
OESNone listed
Jul 20, 2023MEDLINE 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
OESNone listed
Jul 20, 2023MEDLINE 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
OESNone listed
Jul 20, 2023MEDLINE 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
OESNone listed
Apr 25, 2023ROi CPS LLC
Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
Open, Classified
OESNone listed
Feb 10, 2023MEDLINE INDUSTRIES, LP - Northfield
Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD
Open, Classified
OESNone listed
Feb 6, 2023MEDLINE 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
OESNone listed
Jun 16, 2022American Contract Systems, Inc.
Various Angiography/Cath Lab packs/trays
Open, Classified
OESNone listed
Mar 22, 2022American Contract Systems, Inc.
ACS Cath Lab Pack
Open, Classified
OESNone listed
Apr 13, 2020American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Terminated
OESNone listed
Feb 18, 2020Avid 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
OESNone listed
Apr 24, 2019Centurion Medical Products Corporation
TRIPLE LUMEN CVC 20CM BUNDLE STCVC2040
Terminated
OESK171957
Apr 24, 2019Centurion Medical Products Corporation
VANTEX 7FR, 16CM, 3L CVC BUNDLE ECVC6670
Terminated
OESK171957
Apr 24, 2019Centurion Medical Products Corporation
OR VANTEX 7FR 3L 16CM CVC ECVC6665
Terminated
OESK171957
Apr 24, 2019Centurion Medical Products Corporation
CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545A
Terminated
OESK171957
Apr 24, 2019Centurion Medical Products Corporation
CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545
Terminated
OESK171957
Apr 24, 2019Centurion Medical Products Corporation
CENTRAL LINE BUNDLE ECVC6375
Terminated
OESK171957
Apr 24, 2019Centurion Medical Products Corporation
CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355
Terminated
OESK171957
Apr 24, 2019Centurion Medical Products Corporation
CVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070
Terminated
OESK171957
Apr 24, 2019Centurion Medical Products Corporation
CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065
Terminated
OESK171957
Apr 24, 2019Centurion Medical Products Corporation
CVC BUNDLE MULTIMED, 3L, 20CM ECVC6060
Terminated
OESK171957
Apr 24, 2019Centurion Medical Products Corporation
CVC BUNDLE, 20CM, 3L, PI ECVC5120A
Terminated
OESK171957
Apr 24, 2019Centurion Medical Products Corporation
CVC BUNDLE, 20CM, 3L, PI ECVC5120
Terminated
OESK171957
Apr 24, 2019Centurion Medical Products Corporation
CVC BUNDLE, 20CM, 4L, PI ECVC5095
Terminated
OESK171957
Apr 24, 2019Centurion Medical Products Corporation
CENTRAL VENOUS ACCESS DEVICE BUNDLE ECVC2840
Terminated
OESK171957
Apr 24, 2019Centurion Medical Products Corporation
TRIPLE LUMEN BUNDLE KIT ECVC1540
Terminated
OESK171957
Oct 26, 2018Merit Medical Systems, Inc.
Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
Terminated
OESNone listed

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