Suction Collection Bottle, Disposable
FDA 510(k) K810574 · Harvard Laboratories
510(k) numberK810574
Submission
- Device name
- Suction Collection Bottle, Disposable
- Applicant
- Harvard Laboratories
Mchenry, IL, US - Received
- March 3, 1981
- Decision date
- April 21, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDQ – Bottle, Collection, Vacuum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
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| 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 |
More from Davol, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K822765 | Sigmoidoscope, FlexibleFAM · Traditional | 11/17/1982SE |
| K810573 | Tube Feeding SetKNT · Traditional | 04/23/1981SE |
| K800879 | Clear Plastic Connecting TubesFPK · Traditional | 06/17/1980SE |
| K800878 | Secondary I.V. Tubing SetsFPA · Traditional | 06/17/1980SE |
| K800877 | Anesthesia Extension TubesFPK · Traditional | 06/17/1980SE |
| K800880 | Plastic Tubing Adapters 5-IN-1-DTL · Traditional | 05/14/1980SE |
| K800881 | Disposable Berman AirwaysCAE · Traditional | 05/08/1980SE |
Questions and answers
When was Suction Collection Bottle, Disposable cleared by the FDA?
Suction Collection Bottle, Disposable (K810574) received a 510(k) decision of Substantially Equivalent on April 21, 1981, 49 days after the submission was received.
What is the product code of K810574?
The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.