Sentrant Introducer Sheath with Hydrophilic Coating
FDA 510(k) K171866 · Medtronic Vascular, Inc.
510(k) numberK171866
Submission
- Device name
- Sentrant Introducer Sheath with Hydrophilic Coating
- Applicant
- Medtronic Vascular, Inc.
Santa Rosa, CA, US - Received
- June 22, 2017
- Decision date
- December 20, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K232570 | Steerant Super Stiff GuidewireDQX · Traditional | 10/24/2023SE |
| K232190 | 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide CatheterDQY · Special | 08/22/2023SE |
| K230156 | 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F…DQY · Special | 06/30/2023SE |
| K220773 | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and…MAV · Special | 04/13/2022SE |
| K192296 | Medtronic 6F Taiga Guiding CatheterDQY · Special | 09/20/2019SE |
| K182957 | Heli-FX EndoAnchor SystemOTD · Special | 11/21/2018SE |
| K173515 | Admiral XtremeLIT · Traditional | 04/12/2018SE |
| K170191 | SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemMCW · Special | 06/16/2017SE |
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteOTD · Special | 06/13/2017SE |
| K162097 | InTRAkitDYB · Traditional | 11/17/2016SE |
Questions and answers
When was Sentrant Introducer Sheath with Hydrophilic Coating cleared by the FDA?
Sentrant Introducer Sheath with Hydrophilic Coating (K171866) received a 510(k) decision of Substantially Equivalent on December 20, 2017, 181 days after the submission was received.
What is the product code of K171866?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.