FlexSeal Introducer Sheath with Hydrophilic Coating
FDA 510(k) K190628 · Freudenberg Medical Mis, Inc.
510(k) numberK190628
Submission
- Device name
- FlexSeal Introducer Sheath with Hydrophilic Coating
- Applicant
- Freudenberg Medical Mis, Inc.
Jeffersonville, IN, US - Received
- March 12, 2019
- Decision date
- May 30, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
Questions and answers
When was FlexSeal Introducer Sheath with Hydrophilic Coating cleared by the FDA?
FlexSeal Introducer Sheath with Hydrophilic Coating (K190628) received a 510(k) decision of Substantially Equivalent on May 30, 2019, 79 days after the submission was received.
What is the product code of K190628?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.