Merit Mak (Mini Access Kit) with Palladium Tip Guide Wire
FDA 510(k) K091584 · Merit Medical Systems, Inc.
510(k) numberK091584
Submission
- Device name
- Merit Mak (Mini Access Kit) with Palladium Tip Guide Wire
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- June 2, 2009
- Decision date
- October 9, 2009
- 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
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| K253616 | ProtekDilate Vascular Access KitDRE · Special | Sorin Group Italia S.R.L. | 12/19/2025SE |
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| 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 |
|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional | 07/27/2026SE |
| K262086 | PreludeSYNC Radial Compression DeviceDXC · Special | 07/22/2026SE |
| K254073 | StatSeal DiscFRO · Traditional | 05/13/2026SE |
| K251802 | STAR RF Ablation SystemGXI · Traditional | 02/13/2026SE |
| K252892 | SCOUT MD Surgical Guidance SystemNEU · Traditional | 12/19/2025SE |
| K250853 | Merit SyringeFMF · Special | 11/04/2025SE |
| K251265 | Resilience Fully Covered Esophageal Stent SystemESW · Traditional | 07/23/2025SE |
| K250909 | Prelude Wave Hydrophilic Sheath IntroducerDYB · Special | 04/25/2025SE |
| K242873 | Ventrax Delivery SystemDQY · Special | 01/15/2025SE |
| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | 01/15/2025SE |
Questions and answers
When was Merit Mak (Mini Access Kit) with Palladium Tip Guide Wire cleared by the FDA?
Merit Mak (Mini Access Kit) with Palladium Tip Guide Wire (K091584) received a 510(k) decision of Substantially Equivalent on October 9, 2009, 129 days after the submission was received.
What is the product code of K091584?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.