# K031691: Merit Mak (Mini Access Kit)

- Pathway: 510(k) (Abbreviated)
- Applicant: Merit Medical Systems, Inc.
- Decided: Sep 3, 2003 after 93 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Micropuncture Introducer Set: named in the summary without a submission number

## Most influential descendants
- K091584: Merit Mak (Mini Access Kit) with Palladium Tip Guide Wire (2009), 2 descendants of its own
- K232609: Micro Ace™ Advanced Micro Access System (2023), 1 descendant of its own
- K130730: V-Stick Vascular Access Set (2013), 1 descendant of its own
- K261640: Merit MAK Nitinol/Gold-Tungsten Guide Wire (2026), 0 descendants of its own
- K253741: V•Stick™ Vascular Access Set (2025), 0 descendants of its own

## Recalls of this device
- Jul 20, 2004 · Not classified · Z-1311-04: Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.
- Jul 20, 2004 · Not classified · Z-1310-04: Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.
- Jul 20, 2004 · Not classified · Z-1309-04: Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.

## Indications for use
The Merit® MAK (Mini Access Kit) is intended for percutaneous placement of a 0.035” (0.89mm) or 0.038” (0.97mm) guide wire into the vascular system.

Source page: https://510kreport.com/device/K031691
Methodology: https://510kreport.com/methodology