French Percutaneous Sheath Introducer
FDA 510(k) K830813 · Norton Performance Plastics Corp.
510(k) numberK830813
Submission
- Device name
- French Percutaneous Sheath Introducer
- Applicant
- Norton Performance Plastics Corp.
Mchenry, IL, US - Received
- March 14, 1983
- Decision date
- April 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253526 | NAMIC Dilator and SheathDYB · Traditional | Medline Industries, LP | 07/29/2026SE |
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…DYB · Traditional | Hartman Medical Group, LLC | 07/06/2026SE |
| K261242 | SimplGuideDYB · Traditional | Pendracare | 06/25/2026SE |
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | Health Line International Corporation | 06/22/2026SE |
| K261492 | FieldFlex Steerable SheathDYB · Special | CenterPoint Systems, LLC | 06/05/2026SE |
| K260606 | Echo Large Bore Introducer SheathDYB · Traditional | Echo Medical, LLC | 04/29/2026SE |
| K254248 | Introducer Sheath SetDYB · Traditional | Cardiocycle Medical(Suzhou) Co., Ltd. | 04/23/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | Edwards Lifesciences | 04/17/2026SE |
| K260091 | Aventus Introducer SheathDYB · Traditional | Inquis Medical | 04/13/2026SE |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001)DYB · Traditional | Protaryx Medical, Inc. | 04/10/2026SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K853791 | Norton Cardioplegic Quick Cooling Coil 421738-000DTR · Traditional | 12/09/1985SE |
| K852914 | Angiographic, Wedge Press, Dual Thermod & InfusionDQY · Traditional | 09/25/1985SE |
| K851299 | Correct FloFPA · Traditional | 05/07/1985SE |
| K842858 | Fluid Administration Line W/Spike 14-923FPA · Traditional | 09/11/1984SE |
| K841828 | Central Venous Catheter W/Big-GardDQY · Traditional | 07/13/1984SE |
| K840240 | Microfuse Intravenous Catheter SetDQY · Traditional | 04/17/1984SE |
| K831587 | Temp. Repair Kit-Dual Lumen CatheterLJS · Traditional | 10/19/1983SE |
| K831698 | Disposable Pressure TRANSDUCER#14004195DRS · Traditional | 08/11/1983SE |
| K830788 | Central Vein Catherization KIT-14-690-DQO · Traditional | 04/30/1983SE |
| K830969 | Perm. Repair Kit for Leonard Norton DualLJS · Traditional | 04/14/1983SE |
Questions and answers
When was French Percutaneous Sheath Introducer cleared by the FDA?
French Percutaneous Sheath Introducer (K830813) received a 510(k) decision of Substantially Equivalent on April 28, 1983, 45 days after the submission was received.
What is the product code of K830813?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.