Atrium 2000 Chest Drain
FDA 510(k) K912704 · Atrium Medical Corp.
510(k) numberK912704
Submission
- Device name
- Atrium 2000 Chest Drain
- Applicant
- Atrium Medical Corp.
Hollis, NH, US - Received
- June 19, 1991
- Decision date
- August 26, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|---|
| K081718 | Express Chest DrainKDQ · Special | Atrium Medical Corp. | 07/25/2008SE |
| 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 |
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| K151386 | C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR MosaicFTL · Traditional | 10/22/2015SE |
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| 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 Atrium 2000 Chest Drain cleared by the FDA?
Atrium 2000 Chest Drain (K912704) received a 510(k) decision of Substantially Equivalent on August 26, 1991, 68 days after the submission was received.
What is the product code of K912704?
The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.