# K810675: Arrow Radial Artery Catheterization Set

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Mar 27, 1981 after 15 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 32 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
63 later devices descend from it; 9 cite it directly.
5 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962746: Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit (1996), 44 descendants of its own
- K082644: Glidesheath (2008), 41 descendants of its own
- K102008: Glidesheath (2010), 17 descendants of its own
- K122980: Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM* ES6F16HQ, Glidesheath Slender Model RM * RS6J10PQ (2012), 12 descendants of its own
- K142183: Glidesheath Slender (2014), 8 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2397-2026: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffect
- Jul 26, 2024 · Class II · Z-3299-2024: Reports have been received regarding open seals on the packaging.
- Dec 12, 2019 · Class II · Z-0844-2020: The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit
- Apr 11, 2018 · Class II · Z-1972-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1969-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1970-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1971-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-1968-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-2019-2018: Product sterility may be compromised due to unsealed packaging.
- Dec 22, 2017 · Class II · Z-1330-2018: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
- Oct 26, 2017 · Class II · Z-1286-2018: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
- Oct 26, 2017 · Class II · Z-1281-2018: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
- Oct 26, 2017 · Class II · Z-1285-2018: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
- Oct 26, 2017 · Class II · Z-1283-2018: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
- Oct 26, 2017 · Class II · Z-1284-2018: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
- Oct 26, 2017 · Class II · Z-1282-2018: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
- Jul 10, 2017 · Class II · Z-0486-2018: Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
- May 9, 2017 · Class II · Z-2327-2017: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- Aug 8, 2016 · Class II · Z-2740-2016: Shipping carton labeling error.
- Aug 8, 2016 · Class II · Z-2741-2016: Shipping carton labeling error.
- Jun 2, 2016 · Class II · Z-2202-2016: Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.
- Jun 2, 2016 · Class II · Z-2201-2016: Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.
- Aug 6, 2014 · Class II · Z-0066-2015: The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and 
- Oct 29, 2010 · Not classified · Z-1356-2011: Sterility may be compromised.
- Oct 29, 2010 · Not classified · Z-1359-2011: Sterility may be compromised.
- Oct 29, 2010 · Not classified · Z-1346-2011: Sterility may be compromised.
- Oct 29, 2010 · Not classified · Z-1360-2011: Sterility may be compromised.
- Oct 29, 2010 · Not classified · Z-1357-2011: Sterility may be compromised.
- Oct 29, 2010 · Not classified · Z-1358-2011: Sterility may be compromised.
- Oct 29, 2010 · Not classified · Z-1355-2011: Sterility may be compromised.
- Jul 29, 2010 · Not classified · Z-2494-2010: Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle
- Jul 29, 2010 · Not classified · Z-2495-2010: Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle

Source page: https://510kreport.com/device/K810675
Methodology: https://510kreport.com/methodology