# K051655: Angiodynamics, Inc., Micro Access Kits

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Sep 12, 2005 after 83 days
- Product code: DQR (Cannula, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1300
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Oct 14, 2020 · Class II · Z-0418-2021: 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component
- Sep 28, 2016 · Class III · Z-0776-2017: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotatin
- Sep 28, 2016 · Class III · Z-0773-2017: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotatin
- Sep 28, 2016 · Class III · Z-0772-2017: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotatin
- Sep 28, 2016 · Class III · Z-0774-2017: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotatin
- Sep 28, 2016 · Class III · Z-0775-2017: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotatin
- Sep 28, 2016 · Class II · Z-0777-2017: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotatin
- Sep 28, 2016 · Class III · Z-0778-2017: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotatin
- Apr 30, 2013 · Class II · Z-1405-2013: AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit coul

## Indications for use
The AngioDynamics, Inc. Micro Access Kit is indicated for percutaneous introduction of a guidewire or catheter into the vascular system following a small 21-gauge needle stick.

Source page: https://510kreport.com/device/K051655
Methodology: https://510kreport.com/methodology