NAMIC Dilator and Sheath
FDA 510(k) K253526 · Medline Industries, LP
510(k) numberK253526
Submission
- Device name
- NAMIC Dilator and Sheath
- Applicant
- Medline Industries, LP
Northfiled, IL, US - Received
- November 13, 2025
- Decision date
- July 29, 2026
- 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 |
| K260942 | AuST Steerable SheathDYB · Special | CenterPoint Systems, LLC | 04/07/2026SE |
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Questions and answers
When was NAMIC Dilator and Sheath cleared by the FDA?
NAMIC Dilator and Sheath (K253526) received a 510(k) decision of Substantially Equivalent on July 29, 2026, 258 days after the submission was received.
What is the product code of K253526?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.