ClearanceBrief
Panels › Cardiovascular › Product code LDF · Class 2

Electrode, Pacemaker, Temporary

Regulation 870.3680

1510(k)s in 12 months (130 all time)
1recalls in 12 months (15 all time)
14recalls that name a 510(k)
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Top companies in LDF

Company510(k)sRecalls
Medtronic Vascular210
C.R. Bard, Inc.80
Electro-Catheter Corp.70
Medtronic51
Oscor, Inc.42
Cordis Corp.50
ETHICON, Inc.50
ARROW INTERNATIONAL, LLC04
Oscor Medical Corp.40
Daig Corp.30
DateFirm and productCodeLinked 510(k)
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU
Open, Classified		 LDFK960479
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J;
Open, Classified		 LDFK803086
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4)
Open, Classified		 LDFNone listed
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223
Open, Classified		 LDFK803086
Jun 21, 2019Alto Development Corp
A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 M
Terminated		 LDFK803086
Nov 8, 2018Oscor, Inc.
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed
Terminated		 LDFK861403
K884866
Jun 16, 2016Medtronic Inc., Cardiac Rhythm and Heart Failure
Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005
Terminated		 LDFK042190
May 30, 2013Heart Sync, Inc
Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in connection with a defibrillator to deli
Terminated		 LDFK080421
May 30, 2013Heart Sync, Inc
Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes Used in connection with a defibrill
Terminated		 LDFK080421
Oct 29, 2012Oscor, Inc.
Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
Terminated		 LDFK831695
Feb 15, 2012European Custom Manufacturing B.V.
Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Manufacturer ECM B.V. Oost-Om 54, P.O. Box 53, NL 5420 AB GEMERT ---
Terminated		 LDFK033858
Jun 24, 2009Arrow International Inc
Arrow Balloon and stylet temporary pacing catheter
Terminated		 LDFK960479
Apr 14, 2009Medtronic Inc
Medtronic STREAMLINE Bipolar Temporary Myocardial Pacing Lead, 6495, Sterile EO, REF 6495F, Medtronic, INC., Minneapolis, MN 55432
Terminated		 LDFK963898
Sep 16, 2008Arrow International Inc
Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-IK, Lot number RF8015920, For Export Only, 5 Fr. (110 cm) Pacing Catheter, 6 Fr. Introducer Sheath, .035 inch diameter spring-wire g
Terminated		 LDFK960479
Sep 16, 2008Arrow International Inc
Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-KS, Lot number RF8015919, 5 Fr. (110 cm) Pacing Catheter, 6 Fr. Introducer Sheath, .035 inch diameter spring-wire guide, Single use.
Terminated		 LDFK960479

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