Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath
FDA 510(k) K142301 · Cook Vascular, Inc.
510(k) numberK142301
Submission
- Device name
- Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath
- Applicant
- Cook Vascular, Inc.
Vandergrift, PA, US - Received
- August 18, 2014
- Decision date
- November 12, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1310
- Specialty
- Cardiovascular
Other 510(k)s with product code DRE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional | Merit Medical Systems, Inc. | 07/27/2026SE |
| K253616 | ProtekDilate Vascular Access KitDRE · Special | Sorin Group Italia S.R.L. | 12/19/2025SE |
| K251325 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 05/29/2025SE |
| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | Merit Medical Systems, Inc. | 01/15/2025SE |
| K241720 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 07/12/2024SE |
| K233647 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 12/14/2023SE |
| K232609 | Micro Ace Advanced Micro Access SystemDRE · Special | Merit Medical Systems, Inc. | 09/27/2023SE |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special | Spectranetics, Inc. | 12/15/2022SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | Spectranetics, Inc. | 08/24/2022SE |
| K211679 | Xtractor deviceDRE · Traditional | Xcardia Innovation , Ltd. | 02/17/2022SE |
More from Xcardia Innovation , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K141148 | Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL…DRE · Traditional | 07/01/2014SE |
| K110347 | Doppler MonitorDPW · Special | 03/16/2011SE |
| K083482 | Cook Vascular Vital-Ject Power Injectable Safety Infusion SetFPA · Traditional | 04/02/2009SE |
| K081425 | Cook Vascular Inc. Vital-Port Vascular Access System Power Injectable PortLJT · Traditional | 09/30/2008SE |
| K061000 | Evolution Mechanical Dilator Sheath Set MODELS-LR-EVN-7.0, LR-EVN-9.0DRE · Special | 05/10/2006SE |
| K032223 | Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic Intermittent…GEI · Traditional | 10/15/2003SE |
| K023937 | Cook Vascular Serpenta Coronary Sinus Introducer SystemDYB · Traditional | 05/27/2003SE |
| K022649 | Cook-Swartz Doppler Flow ProbeITX · Special | 09/06/2002SE |
| K010128 | Cook Vascular Peel-Away Hemostasis ValveDYB · Traditional | 04/25/2002SE |
| K002958 | Shapeable Doppler Flow ProbeITX · Traditional | 12/18/2001SE |
Questions and answers
When was Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath cleared by the FDA?
Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath (K142301) received a 510(k) decision of Substantially Equivalent on November 12, 2014, 86 days after the submission was received.
What is the product code of K142301?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.