Express Chest Drain
FDA 510(k) K081718 · Atrium Medical Corp.
510(k) numberK081718
Submission
- Device name
- Express Chest Drain
- Applicant
- Atrium Medical Corp.
Hudson, NH, US - Received
- June 18, 2008
- Decision date
- July 25, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KDQ – Bottle, Collection, Vacuum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code KDQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K062302 | Millicore AB Digivent Chest Drainage SystemKDQ · Traditional | Millicore AB | 10/06/2006SE |
| K043582 | Ocean Chest DrainKDQ · Special | Atrium Medical Corp. | 01/21/2005SE |
| K984496 | Atrium Medical Corporation Express Chest DrainKDQ · Traditional | Atrium Medical Corp. | 05/05/1999SE |
| K962856 | Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100…KDQ · Traditional | Deknatel, Inc. | 08/28/1996SE |
| K961287 | Rocket Pleuraseal II Chest Drainage SystemKDQ · Traditional | Rocket Medical Plc | 07/26/1996SE |
| K962168 | Mucus Specimen TrapKDQ · Traditional | Sage Products, Inc. | 07/22/1996SE |
| K950677 | Atrium Dry Suction Control Water Seal Chest DrainKDQ · Traditional | Atrium Medical Corp. | 04/13/1995SE |
| K941818 | PM9000 Vac TrapKDQ · Traditional | Precision Medical, Inc. | 12/12/1994SE |
| K932327 | Thora-Klex 350 ML Pediatric Chest Drainage SystemKDQ · Traditional | Davol, Inc. | 07/13/1993SE |
| K912704 | Atrium 2000 Chest DrainKDQ · Traditional | Atrium Medical Corp. | 08/26/1991SE |
More from Atrium Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular GraftDSY · Traditional | 03/28/2024SE |
| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…CAC · Traditional | 09/03/2021SE |
| K151386 | C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR MosaicFTL · Traditional | 10/22/2015SE |
| K151437 | ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh PlugFTL · Traditional | 08/27/2015SE |
| K130142 | Flixene Ifg Vascular GraftDSY · Traditional | 03/15/2013SE |
| K130131 | Edrain Chest Drainage SystemBTA · Traditional | 02/28/2013SE |
| K122138 | Atrium Flixene Ifg Vascular GraftDSY · Special | 08/17/2012SE |
| K121070 | C-Qur RPM MeshFTL · Special | 04/26/2012SE |
| K113112 | Clearway RX NB CatheterDQY · Special | 11/17/2011SE |
| K110110 | Atrium Centrilfx MeshFTL · Special | 02/15/2011SE |
Questions and answers
When was Express Chest Drain cleared by the FDA?
Express Chest Drain (K081718) received a 510(k) decision of Substantially Equivalent on July 25, 2008, 37 days after the submission was received.
What is the product code of K081718?
The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.