Chemotherapy Infusion Catheter
FDA 510(k) K822096 · American Heyer Schulte
510(k) numberK822096
Submission
- Device name
- Chemotherapy Infusion Catheter
- Applicant
- American Heyer Schulte
Walker, MI, US - Received
- July 16, 1982
- Decision date
- April 12, 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 |
| K831451 | Silcath Central Catheter Tray Size-JCY · Traditional | Argon Medical Corp. | 06/08/1983SE |
| 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 |
|---|---|---|
| K840172 | Ventral Wall Defect Reduct SiloFTL · Traditional | 06/27/1984SE |
| K834593 | One-Piece ShuntJXG · Traditional | 04/03/1984SE |
| K833502 | Radovan Subcutaneous Tissue ExpanderLCJ · Traditional | 02/03/1984SE |
| K833698 | Amer. V. Mueller Surg. Staples IlaGDW · Traditional | 01/25/1984SE |
| K833704 | Amer. V. Mueller Surgicalstaples-CartrGDW · Traditional | 12/29/1983SE |
| K832738 | Heyer-Schulte Afterloading CatheterIWJ · Traditional | 09/29/1983SE |
| K823790 | Ventricular Access SystemLKG · Traditional | 04/28/1983SE |
| K822032 | Large Volume Closed Wound Suction DrainGCY · Traditional | 08/16/1982SE |
| K820247 | External Ventricular Drainage Sys.JXG · Traditional | 02/18/1982SE |
| K811288 | Spetzler Lumbar-Peritoneal SystemJXG · Traditional | 06/26/1981SE |
Questions and answers
When was Chemotherapy Infusion Catheter cleared by the FDA?
Chemotherapy Infusion Catheter (K822096) received a 510(k) decision of Substantially Equivalent on April 12, 1983, 270 days after the submission was received.
What is the product code of K822096?
The FDA product code is JCY – Catheter, Infusion, a Class I (low risk) device regulated under 21 CFR 878.4200.