Walrus Percutaneous Introducer Set
FDA 510(k) K831239 · Medical Parameters, Inc.
510(k) numberK831239
Submission
- Device name
- Walrus Percutaneous Introducer Set
- Applicant
- Medical Parameters, Inc.
Mchenry, IL, US - Received
- April 15, 1983
- Decision date
- May 25, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DOY – Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DOY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K910154 | Usci ILLUMEN-8 8F Ptca Guiding CatheterDOY · Traditional | C.R. Bard, Inc. | 04/09/1991SE |
| K832396 | Central Venous Access Catheter CvacDOY · Traditional | Gish Biomedical, Inc. | 08/31/1983SE |
| K831191 | Vascular CatheterDOY · Traditional | Medrad, Inc. | 05/09/1983SE |
| K831188 | Connector TubeDOY · Traditional | Medrad, Inc. | 05/09/1983SE |
More from Medrad, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K862190 | Walrus: Double Balloon Shunting CatheterDWF · Traditional | 11/03/1986SE |
| K844444 | Esophageal StethoscopeBZW · Traditional | 01/10/1985SE |
| K833825 | Multi-Lumen Intravenous Infusion CathDQY · Traditional | 01/10/1984SE |
| K830754 | Blood Pressure Monitoring Kits,WalrusDXT · Traditional | 08/12/1983SE |
| K830755 | I.V. Sets Walrus Brand Various Configur-FPA · Traditional | 04/28/1983SE |
Questions and answers
When was Walrus Percutaneous Introducer Set cleared by the FDA?
Walrus Percutaneous Introducer Set (K831239) received a 510(k) decision of Substantially Equivalent on May 25, 1983, 40 days after the submission was received.
What is the product code of K831239?
The FDA product code is DOY – Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3320.