Thinline Sheath Introducer
FDA 510(k) K232260 · Inneuroco, Inc.
510(k) numberK232260
Submission
- Device name
- Thinline Sheath Introducer
- Applicant
- Inneuroco, Inc.
Pembroke Pines, FL, US - Received
- July 31, 2023
- Decision date
- September 27, 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
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 |
|---|---|---|
| K220331 | 091 Balloon Guide CatheterDQY · Traditional | 07/29/2022SE |
| K190338 | 046 Zenith FlexNRY · Traditional | 08/02/2019SE |
| K181354 | 074 Zenith Flex SystemNRY · Traditional | 10/25/2018SE |
| K172167 | Zenith Flex SystemNRY · Traditional | 04/19/2018SE |
| K173709 | Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cmDQY · Special | 01/26/2018SE |
| K172468 | 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmDQY · Traditional | 12/06/2017SE |
| K171672 | 065 Zenith, 074 ZenithDQY · Traditional | 10/19/2017SE |
| K161262 | Super Distal Access (SDA)DQY · Traditional | 09/19/2016SE |
Questions and answers
When was Thinline Sheath Introducer cleared by the FDA?
Thinline Sheath Introducer (K232260) received a 510(k) decision of Substantially Equivalent on September 27, 2023, 58 days after the submission was received.
What is the product code of K232260?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.