Bush Neck W/Tap
FDA 510(k) K841410 · Warne Surgical Products, Ltd.
510(k) numberK841410
Submission
- Device name
- Bush Neck W/Tap
- Applicant
- Warne Surgical Products, Ltd.
Mchenry, IL, US - Received
- April 5, 1984
- Decision date
- April 18, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRM – Compressor, Cardiac, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5200
- Specialty
- Cardiovascular
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|---|---|---|---|
| K221700 | AutoPulse NXT Resuscitation SystemDRM · Traditional | Zoll Circulation, Inc. | 03/09/2023SE |
| K211289 | RMU-2000 Automated Chest Compression SystemDRM · Traditional | Defibtech, LLC | 11/09/2021SE |
| K173553 | LUCAS 3 Chest Compression SystemDRM · Traditional | Jolife AB | 02/08/2018SE |
| K161768 | LUCAS 3 Chest Compression SystemDRM · Traditional | Jolife AB | 11/09/2016SE |
| K153628 | ROSC-U Mini Chest Compressor (RMCC)DRM · Traditional | Resuscitation International, LLC | 01/30/2016SE |
| K141809 | RMU-1000 Automated Chest Compression SystemDRM · Traditional | Defibtech, LLC | 10/27/2014SE |
| K112998 | Autopulse Resuscitation System Model 1000DRM · Traditional | Zoll Circulation | 03/15/2012SE |
| K102068 | Miniaturize Chest Compressor (MCC)DRM · Traditional | Resuscitation International | 11/16/2010SE |
| K090422 | Lucas 2DRM · Traditional | Jolife AB | 06/17/2009SE |
| K072527 | Autopulse Resuscitation System, Model 100DRM · Traditional | Zoll Circulation | 03/19/2008SE |
More from Zoll Circulation
| 510(k) | Device | Decision |
|---|---|---|
| K850696 | WSP Code 4300 Diomaster DiagnosticFAP · Traditional | 05/17/1985SE |
| K850694 | WSP Code 4310 StresscathFAP · Traditional | 05/17/1985SE |
| K850695 | WSP Code 4301 Diomaster TherapeuticFAP · Traditional | 05/16/1985SE |
| K850693 | WSP Code 4315 PadtestFAP · Traditional | 05/10/1985SE |
| K841511 | Haematuria CathetersKOD · Traditional | 07/12/1984SE |
| K840687 | Kidney Transplant CatheterKDN · Traditional | 06/07/1984SE |
| K841412 | Rolled Neck W/TapBTC · Traditional | 04/18/1984SE |
| K841411 | Rolled Neck W/PlugBTC · Traditional | 04/18/1984SE |
| K841409 | Bush Neck W/PlugBYZ · Traditional | 04/18/1984SE |
| K840704 | Secure W/35MM Diam, Sheath/AdhesiveKNX · Traditional | 03/22/1984SE |
Questions and answers
When was Bush Neck W/Tap cleared by the FDA?
Bush Neck W/Tap (K841410) received a 510(k) decision of Substantially Equivalent on April 18, 1984, 13 days after the submission was received.
What is the product code of K841410?
The FDA product code is DRM – Compressor, Cardiac, External, a Class II (moderate risk) device regulated under 21 CFR 870.5200.