Vas-Cath Pericardiocentesis Catheter, Set & Tray
FDA 510(k) K863982 · Vas-Cath of Canada , Ltd.
510(k) numberK863982
Submission
- Device name
- Vas-Cath Pericardiocentesis Catheter, Set & Tray
- Applicant
- Vas-Cath of Canada , Ltd.
Ontario, L5a 3v3, CA - Received
- October 14, 1986
- Decision date
- October 24, 1986
- 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 |
|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K875188 | Luer Lock Connectors / Ridig P.V.C.LFJ · Traditional | 03/02/1988SE |
| K871817 | Vas-Cath Peritoneal Dialysis CatheterFJS · Traditional | 07/16/1987SE |
| K871488 | Vas-Cath Permanent Dual Lumen Hemodialysis CathLFJ · Traditional | 06/12/1987SE |
| K871487 | Vas-Cath Permanent Single Lumen Hemodialysis CathLFJ · Traditional | 06/12/1987SE |
| K853283 | Vaccess TM 4006LFJ · Traditional | 08/22/1985SE |
| K844854 | Opti-Flow Digital Subtraction Angiography Cat-KitDQO · Traditional | 05/21/1985SE |
| K844800 | Opti-Flow & Opti-Torque Angiographic CathetersDQO · Traditional | 05/16/1985SE |
| K850009 | Evans, Vas-Cath Epidural Needle & CatheterBSO · Traditional | 05/13/1985SE |
| K844434 | Vaccess 3000 Single Lumen Jugular Cannula-CathLFJ · Traditional | 03/13/1985SE |
| K844433 | Vaccess 2000 Single Lumen Subclavian CannulaLFJ · Traditional | 03/13/1985SE |
Questions and answers
When was Vas-Cath Pericardiocentesis Catheter, Set & Tray cleared by the FDA?
Vas-Cath Pericardiocentesis Catheter, Set & Tray (K863982) received a 510(k) decision of Substantially Equivalent on October 24, 1986, 10 days after the submission was received.
What is the product code of K863982?
The FDA product code is JCY – Catheter, Infusion, a Class I (low risk) device regulated under 21 CFR 878.4200.