Mucus Trap or Suction Trap
FDA 510(k) K881149 · Ferguson Medical
510(k) numberK881149
Submission
- Device name
- Mucus Trap or Suction Trap
- Applicant
- Ferguson Medical
Chico, CA, US - Received
- March 17, 1988
- Decision date
- June 14, 1988
- 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
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 |
More from Davol, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K033153 | Dicom TheaterLLZ · Traditional | 04/23/2004SE |
| K963794 | PunctureneedleKNW · Traditional | 03/19/1998SE |
| K962615 | Tumorlocalizer MRIMIG · Traditional | 03/19/1998SE |
| K971813 | EmblaOLV · Traditional | 01/16/1998SE |
| K972219 | Orthopedic Plate SystemHRS · Traditional | 11/20/1997SE |
| K972217 | Orthopedic Screw SystemHWC · Traditional | 11/20/1997SE |
| K970819 | TargobeamJAK · Traditional | 07/14/1997SE |
| K970280 | Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Per-Trochanteroam…HSB · Traditional | 05/22/1997SE |
| K970258 | Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck…HRS · Traditional | 05/22/1997SE |
| K970257 | Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Sub-Trochanterian…HSB · Traditional | 05/22/1997SE |
Questions and answers
When was Mucus Trap or Suction Trap cleared by the FDA?
Mucus Trap or Suction Trap (K881149) received a 510(k) decision of Substantially Equivalent on June 14, 1988, 89 days after the submission was received.
What is the product code of K881149?
The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.