10F Sheath and Dilator Set
FDA 510(k) K233432 · Argon Medical Devices, Inc.
510(k) numberK233432
Submission
- Device name
- 10F Sheath and Dilator Set
- Applicant
- Argon Medical Devices, Inc.
Athens, TX, US - Received
- October 12, 2023
- Decision date
- December 8, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| 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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Questions and answers
When was 10F Sheath and Dilator Set cleared by the FDA?
10F Sheath and Dilator Set (K233432) received a 510(k) decision of Substantially Equivalent on December 8, 2023, 57 days after the submission was received.
What is the product code of K233432?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.