Pleur-Evac A-8002--ADULT/PEDIATRIC Dual Collection
FDA 510(k) K892915 · Deknatel, Inc.
510(k) numberK892915
Submission
- Device name
- Pleur-Evac A-8002--ADULT/PEDIATRIC Dual Collection
- Applicant
- Deknatel, Inc.
San Jose-Heredia, CR - Received
- April 20, 1989
- Decision date
- June 21, 1989
- 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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| 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 |
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More from Davol, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K963850 | Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion SystemCAC · Traditional | 04/22/1997SE |
| K962683 | Snowden-Pencer Computerized High Flow InsufflatorHIF · Traditional | 01/10/1997SE |
| K964070 | Deknatel DSP Pleur-Evac Autotransfusion Blood Recovery BagCAC · Traditional | 12/31/1996SE |
| K963098 | Pleur-Evac Shara Plus Model S-2150/CONTINUOUS Reinfusion Autotransfusion SYSTEM(S-100)CAC · Traditional | 11/08/1996SE |
| K962856 | Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100…KDQ · Traditional | 08/28/1996SE |
| K925243 | Deknatel(Tm) Pleur-Evac(R) Thoracic CatheterGBX · Traditional | 07/27/1994SE |
| K930740 | Surgical Suture, Nonabsorable Stainless SteelGAQ · Traditional | 07/26/1994SE |
| K930739 | Sutures Polyprop., Polyetheline, Nylon & SilkGAP · Traditional | 07/26/1994SE |
| K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcGAL · Traditional | 07/26/1994SE |
| K926338 | Pleur-Evac Cardiotomy Reservoir # CR-9400 & 9400FCAC · Traditional | 07/26/1994SE |
Questions and answers
When was Pleur-Evac A-8002--ADULT/PEDIATRIC Dual Collection cleared by the FDA?
Pleur-Evac A-8002--ADULT/PEDIATRIC Dual Collection (K892915) received a 510(k) decision of Substantially Equivalent on June 21, 1989, 62 days after the submission was received.
What is the product code of K892915?
The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.