Ameco Sheath Introducer
FDA 510(k) K131144 · Ameco Medical Industries
510(k) numberK131144
Submission
- Device name
- Ameco Sheath Introducer
- Applicant
- Ameco Medical Industries
Monroe, CT, US - Received
- April 23, 2013
- Decision date
- August 15, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
Other 510(k)s with product code DYB
| 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 |
More from Protaryx Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K152819 | Amecath Peripheral inserted Central Venous Catheter SetsLJS · Traditional | 02/05/2016SE |
| K131814 | Amecath Dual Lumen Implanted Hemodialysis CatheterMSD · Special | 07/26/2013SESK |
| K123943 | Amecath Dual Lumen Hemodialysis CatheterMSD · Traditional | 04/02/2013SE |
| K110794 | Amecath CVC and Amecath Pressure CVC Short Term Single and Multi-Lumen Catherization KitsFOZ · Traditional | 12/21/2011SE |
| K110793 | Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization KitsMPB · Traditional | 12/16/2011SE |
Questions and answers
When was Ameco Sheath Introducer cleared by the FDA?
Ameco Sheath Introducer (K131144) received a 510(k) decision of Substantially Equivalent on August 15, 2013, 114 days after the submission was received.
What is the product code of K131144?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.