MC3 Vascular Access Kit 21030
FDA 510(k) K182914 · Mc3 Incorporated
510(k) numberK182914
Submission
- Device name
- MC3 Vascular Access Kit 21030
- Applicant
- Mc3 Incorporated
Dexter, MI, US - Received
- October 18, 2018
- Decision date
- October 29, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K232767 | Nautilus VF ECMO OxygenatorBYS · Special | 10/04/2023SE |
| K203409 | MC3 Crescent Jugular Dual Lumen CatheterPZS · Traditional | 05/03/2021SE |
| K191935 | Nautilus Smart ECMO ModuleBYS · Traditional | 04/09/2020SE |
| K180151 | MC3 Jugular Dual Lumen CatheterPZS · Traditional | 07/16/2018SE |
| K171610 | MC3 QuickFlow Dual Lumen CatheterPZS · Traditional | 11/16/2017SE |
Questions and answers
When was MC3 Vascular Access Kit 21030 cleared by the FDA?
MC3 Vascular Access Kit 21030 (K182914) received a 510(k) decision of Substantially Equivalent on October 29, 2018, 11 days after the submission was received.
What is the product code of K182914?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.