External Ventricular Drainage Sys.
FDA 510(k) K820247 · American Heyer Schulte
510(k) numberK820247
Submission
- Device name
- External Ventricular Drainage Sys.
- Applicant
- American Heyer Schulte
Mchenry, IL, US - Received
- January 29, 1982
- Decision date
- February 18, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 510(k) | Device | Decision |
|---|---|---|
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| 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 |
| K822096 | Chemotherapy Infusion CatheterJCY · Traditional | 04/12/1983SE |
| K822032 | Large Volume Closed Wound Suction DrainGCY · Traditional | 08/16/1982SE |
| K811288 | Spetzler Lumbar-Peritoneal SystemJXG · Traditional | 06/26/1981SE |
Questions and answers
When was External Ventricular Drainage Sys. cleared by the FDA?
External Ventricular Drainage Sys. (K820247) received a 510(k) decision of Substantially Equivalent on February 18, 1982, 20 days after the submission was received.
What is the product code of K820247?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.