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)
Top companies in DWS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2025 | Galt Medical Corporation Introducer Needle
REF NDL-107-04
These needles are used for the percutaneous introduction of guidewires Open, Classified |
DWS | None listed |
| Sep 1, 2023 | Cook 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 |
DWS | None listed |
| Jul 31, 2023 | Maquet 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 |
DWS | None listed |
| Jul 31, 2023 | Maquet 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 |
DWS | None listed |
| Jul 31, 2023 | Maquet 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 |
DWS | None listed |
| Jul 31, 2023 | Maquet 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 |
DWS | None listed |
| Feb 9, 2022 | Maquet Cardiovascular, LLC Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001. Open, Classified |
DWS | None listed |
| Feb 19, 2020 | Deroyal 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 |
DWS | None listed |
| Jan 27, 2020 | TELEFLEX 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 |
DWS | None listed |
| Jan 27, 2020 | TELEFLEX MEDICAL INC Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440 Terminated |
DWS | None listed |
| Feb 26, 2018 | Genesee 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 |
DWS | None listed |
| Nov 22, 2016 | Cincinnati Sub-Zero Products Inc The Hemotherm 400CE 115v, containing power board p/n 39945 Terminated |
DWS | K122813 |
| Aug 19, 2015 | International 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 |
DWS | None listed |
| Aug 19, 2015 | International 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 |
DWS | None listed |
| May 2, 2014 | Biorep 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 |
DWS | None listed |
| Jun 13, 2013 | Edwards 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 |
DWS | K981995 |
| May 7, 2013 | Symmetry 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 |
DWS | None listed |
| Feb 17, 2011 | St. 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 |
DWS | None listed |
| Nov 1, 2010 | Medtronic 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 |
DWS | None listed |
| Oct 15, 2003 | Rultract Inc Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. Terminated |
DWS | None listed |
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