Guide Sheath
FDA 510(k) K190644 · Surmodics,Inc.
510(k) numberK190644
Submission
- Device name
- Guide Sheath
- Applicant
- Surmodics,Inc.
Eden Prairie, MN, US - Received
- March 13, 2019
- Decision date
- April 18, 2019
- 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 |
|---|---|---|
| K252227 | Pounce(TM) SheathDYB · Special | 09/24/2025SE |
| K241362 | Pounce XL Thrombectomy System (PTS-1011-7F135)QEW · Traditional | 09/11/2024SE |
| K232647 | MicrocatheterDQY · Special | 09/29/2023SE |
| K231828 | Pounce SheathDYB · Traditional | 09/07/2023SE |
| K231022 | Pounce Thrombectomy SystemQEW · Traditional | 06/12/2023SE |
| K221886 | Sublime MicrocatheterDQY · Traditional | 10/14/2022SE |
| K220501 | Pounce Thrombectomy SystemQEW · Special | 03/23/2022SE |
| K211492 | Pounce Thrombectomy SystemQEW · Traditional | 07/30/2021SE |
| K192814 | Pounce Thrombus Retrieval SystemQEW · Traditional | 09/21/2020SE |
| K173560 | MicrocatheterDQY · Traditional | 01/12/2018SE |
Questions and answers
When was Guide Sheath cleared by the FDA?
Guide Sheath (K190644) received a 510(k) decision of Substantially Equivalent on April 18, 2019, 36 days after the submission was received.
What is the product code of K190644?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.