Silicone Elastomer Infusion Catheter
FDA 510(k) K813606 · Quest Medical, Inc.
510(k) numberK813606
Submission
- Device name
- Silicone Elastomer Infusion Catheter
- Applicant
- Quest Medical, Inc.
Mchenry, IL, US - Received
- December 29, 1981
- Decision date
- January 18, 1982
- 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 |
| K840324 | Silicone Sump Drain 20 & 40 FrenchJCY · Traditional | Superior Plastic Products Corp. | 04/25/1984SE |
| 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 |
| 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 |
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Questions and answers
When was Silicone Elastomer Infusion Catheter cleared by the FDA?
Silicone Elastomer Infusion Catheter (K813606) received a 510(k) decision of Substantially Equivalent on January 18, 1982, 20 days after the submission was received.
What is the product code of K813606?
The FDA product code is JCY – Catheter, Infusion, a Class I (low risk) device regulated under 21 CFR 878.4200.