Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL Controlled-Rotation Dilator Sheath Set
FDA 510(k) K141148 · Cook Vascular, Inc.
510(k) numberK141148
Submission
- Device name
- Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL Controlled-Rotation Dilator Sheath Set
- Applicant
- Cook Vascular, Inc.
Vandergrift, PA, US - Received
- May 5, 2014
- Decision date
- July 1, 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 |
|---|---|---|
| K142301 | Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath…DRE · Traditional | 11/12/2014SE |
| 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 RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL Controlled-Rotation Dilator Sheath Set cleared by the FDA?
Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL Controlled-Rotation Dilator Sheath Set (K141148) received a 510(k) decision of Substantially Equivalent on July 1, 2014, 57 days after the submission was received.
What is the product code of K141148?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.