Silicone Sump Drain 20 & 40 French
FDA 510(k) K840324 · Superior Plastic Products Corp.
510(k) numberK840324
Submission
- Device name
- Silicone Sump Drain 20 & 40 French
- Applicant
- Superior Plastic Products Corp.
Mchenry, IL, US - Received
- January 25, 1984
- Decision date
- April 25, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JCY – Catheter, Infusion
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code JCY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K863982 | Vas-Cath Pericardiocentesis Catheter, Set & TrayJCY · Traditional | Vas-Cath of Canada , Ltd. | 10/24/1986SE |
| K834615 | Triple Lumen Infusioncatheters-JCY · Traditional | Medical Components, Inc. | 02/14/1984SE |
| K831453 | Silcath Central Catheter Tray W/18 GaJCY · Traditional | Argon Medical Corp. | 07/28/1983SE |
| K831451 | Silcath Central Catheter Tray Size-JCY · Traditional | Argon Medical Corp. | 06/08/1983SE |
| K822096 | Chemotherapy Infusion CatheterJCY · Traditional | American Heyer Schulte | 04/12/1983SE |
| K813606 | Silicone Elastomer Infusion CatheterJCY · Traditional | Quest Medical, Inc. | 01/18/1982SE |
| K791372 | Jelco & Kvo Catheter Placement UnitJCY · Traditional | Jelco Laboratories | 09/12/1979SE |
| K771861 | Catheter, Cebtral Venous, 2N1501JCY · Traditional | Travenol Laboratories, S.A. | 11/28/1977SE |
| K760760 | Catheter, Intravascular (Argyle IV SK)JCY · Traditional | Sherwood Medical Industries | 12/09/1976SE |
| K760391 | Catheter, Vein (Braunula)JCY · Traditional | B. Braun Instruments | 11/02/1976SE |
More from B. Braun Instruments
| 510(k) | Device | Decision |
|---|---|---|
| K851981 | No. 5300-3 1/2 French Umbilical Vessel Cath. Etc.FOZ · Traditional | 06/18/1985SE |
| K843975 | 9 French 42LONG Polyurethane Graduated Enteric FeKNT · Traditional | 11/20/1984SE |
| K841945 | Enteral Feeding BottleKNT · Traditional | 07/26/1984SE |
| K841630 | Enteral Nutrition PumpFRN · Traditional | 06/07/1984SE |
| K841480 | Infection Control ValveBSY · Traditional | 04/25/1984SE |
| K840323 | Silicone Suction & Irrigation DrainGBX · Traditional | 04/25/1984SE |
| K833687 | Dispos. Enteric Feeding Tubes W/Safe-TKNT · Traditional | 03/02/1984SE |
| K833947 | Superior Enternal Feeding SystemKNT · Traditional | 02/04/1984SE |
| K820460 | 3.5 & 5.5 Oz. Sodium Chloride SolutionJOL · Traditional | 03/08/1982SE |
| K812312 | Sterile Water 4OZ.JOL · Traditional | 11/13/1981SE |
Questions and answers
When was Silicone Sump Drain 20 & 40 French cleared by the FDA?
Silicone Sump Drain 20 & 40 French (K840324) received a 510(k) decision of Substantially Equivalent on April 25, 1984, 91 days after the submission was received.
What is the product code of K840324?
The FDA product code is JCY – Catheter, Infusion, a Class I (low risk) device regulated under 21 CFR 878.4200.