Millicore AB Digivent Chest Drainage System
FDA 510(k) K062302 · Millicore AB
510(k) numberK062302
Submission
- Device name
- Millicore AB Digivent Chest Drainage System
- Applicant
- Millicore AB
North Attleboro, MA, US - Received
- August 8, 2006
- Decision date
- October 6, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
Questions and answers
When was Millicore AB Digivent Chest Drainage System cleared by the FDA?
Millicore AB Digivent Chest Drainage System (K062302) received a 510(k) decision of Substantially Equivalent on October 6, 2006, 59 days after the submission was received.
What is the product code of K062302?
The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.