ClearanceBrief
Panels › Cardiovascular › Product code DWS · Class 1

Instruments, Surgical, Cardiovascular

Regulation 870.4500

0510(k)s in 12 months (71 all time)
0recalls in 12 months (20 all time)
2recalls that name a 510(k)
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Top companies in DWS

DateFirm and productCodeLinked 510(k)
May 7, 2025Galt Medical Corporation
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Open, Classified
DWSNone listed
Sep 1, 2023Cook Vandergrift, Inc.
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
Open, Classified
DWSNone listed
Jul 31, 2023Maquet Cardiovascular, LLC
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
Open, Classified
DWSNone listed
Jul 31, 2023Maquet Cardiovascular, LLC
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
Open, Classified
DWSNone listed
Jul 31, 2023Maquet Cardiovascular, LLC
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
Open, Classified
DWSNone listed
Jul 31, 2023Maquet Cardiovascular, LLC
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.
Open, Classified
DWSNone listed
Feb 9, 2022Maquet Cardiovascular, LLC
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Open, Classified
DWSNone listed
Feb 19, 2020Deroyal Industries, Inc. Lafollette
Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardiovascular surgical procedures.
Terminated
DWSNone listed
Jan 27, 2020TELEFLEX MEDICAL INC
Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 mm, REF DP-40K d) 4.4 mm, REF DP-44K e) 4.8 mm, REF DP-48K f) 5.2 mm, REF DP-52K g)
Terminated
DWSNone listed
Jan 27, 2020TELEFLEX MEDICAL INC
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
Terminated
DWSNone listed
Feb 26, 2018Genesee BioMedical, Inc.
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
Open, Classified
DWSNone listed
Nov 22, 2016Cincinnati Sub-Zero Products Inc
The Hemotherm 400CE 115v, containing power board p/n 39945
Terminated
DWSK122813
Aug 19, 2015International Biophysics Corp.
IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying a
Terminated
DWSNone listed
Aug 19, 2015International Biophysics Corp.
IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, AP
Terminated
DWSNone listed
May 2, 2014Biorep Technologies
Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.
Terminated
DWSNone listed
Jun 13, 2013Edwards Lifesciences, LLC
QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannu
Terminated
DWSK981995
May 7, 2013Symmetry Medical/SSI
Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor
Terminated
DWSNone listed
Feb 17, 2011St. Jude Medical Cardiovascular Division
MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): A0030/1; A0031/1; A0032/1; A0033/1, Cardio Life Research s.a., Green Hill, Hoge Wei, 16, B-1930 Zaventem, Belgium. Indicted for th
Terminated
DWSNone listed
Nov 1, 2010Medtronic Perfusion Systems
Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus Nuvo Tissue Stabilizer is a disposable tissue stabilization system consisting of a rigid shaft, detachable tissue stabilizer headl
Terminated
DWSNone listed
Oct 15, 2003Rultract Inc
Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Terminated
DWSNone listed

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