# K132713: Nmi Coaxial Microintroducer Set

- Pathway: 510(k) (Special)
- Applicant: Navilyst Medical, Inc.
- Decided: Sep 27, 2013 after 28 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K974640 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123445: Nmi Coaxial Microintroducer Set, Navilyst Medical, Inc. (2013). Our reading of the summary gave K123455, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ministick Max Coaxial Microintroduer Set”.

## Recalls of this device
- Jan 30, 2024 · Class II · Z-1344-2024: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of v
- Jan 30, 2024 · Class II · Z-1343-2024: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of v
- Jan 30, 2024 · Class II · Z-1334-2024: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of v
- Jan 30, 2024 · Class II · Z-1348-2024: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of v
- Jan 30, 2024 · Class II · Z-1338-2024: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of v
- Jan 30, 2024 · Class II · Z-1336-2024: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of v
- Jan 30, 2024 · Class II · Z-1341-2024: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of v
- Jan 30, 2024 · Class II · Z-1346-2024: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of v
- Jan 30, 2024 · Class II · Z-1340-2024: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of v
- Jan 30, 2024 · Class II · Z-1345-2024: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of v
- Jan 30, 2024 · Class II · Z-1335-2024: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of v
- Jan 30, 2024 · Class II · Z-1337-2024: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of v
- Jan 30, 2024 · Class II · Z-1339-2024: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of v
- Jan 30, 2024 · Class II · Z-1347-2024: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of v
- Jan 30, 2024 · Class II · Z-1342-2024: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of v

## Indications for use
The NMI Coaxial Microintroducer Set is used for the percutaneous introduction of a guidewire into the vascular system.

Source page: https://510kreport.com/device/K132713
Methodology: https://510kreport.com/methodology