Silcath Central Catheter Tray Size-
FDA 510(k) K831451 · Argon Medical Corp.
510(k) numberK831451
Submission
- Device name
- Silcath Central Catheter Tray Size-
- Applicant
- Argon Medical Corp.
Mchenry, IL, US - Received
- May 5, 1983
- Decision date
- June 8, 1983
- 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 |
| 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 |
|---|---|---|
| K130730 | V-Stick Vascular Access SetDYB · Special | 11/22/2013SE |
| K904994 | Closed System Flush SetDXT · Traditional | 01/15/1991SE |
| K895511 | Catheter Balloon Dilator Pressure GaugeMAV · Traditional | 02/28/1990SE |
| K894157 | ObturatorDYB · Traditional | 09/28/1989SE |
| K891022 | Introducer for Ptca Guiding CathetersDYB · Traditional | 05/19/1989SE |
| K884375 | Translumbar Aortography Needle CatheterDQR · Traditional | 01/11/1989SE |
| K882221 | Over the Needle Catheter, Arterial Catheter NeedleDYB · Traditional | 08/12/1988SE |
| K871297 | Kadir Hi-Torque Guide WireKOD · Traditional | 04/10/1987SE |
| K853312 | Argon Cut Biopsy Needles, Various SizesDWO · Traditional | 09/12/1985SE |
| K852880 | Peel-Away Sheath(A Component of Argon Introd Set)DYB · Traditional | 08/29/1985SE |
Questions and answers
When was Silcath Central Catheter Tray Size- cleared by the FDA?
Silcath Central Catheter Tray Size- (K831451) received a 510(k) decision of Substantially Equivalent on June 8, 1983, 34 days after the submission was received.
What is the product code of K831451?
The FDA product code is JCY – Catheter, Infusion, a Class I (low risk) device regulated under 21 CFR 878.4200.