# K182985: Roadrunner PC Wire Guide, Olcott Torque Device

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jul 22, 2019 after 266 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920891 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920891: Roadrunner (TM) Wire Guide, Modification, Cook, Inc. (1992) Summary page 4.

## Recalls of this device
- Aug 16, 2022 · Class II · Z-1839-2022: Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
- Aug 16, 2022 · Class II · Z-1840-2022: Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
- Aug 16, 2022 · Class II · Z-1838-2022: Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
- Aug 16, 2022 · Class II · Z-1841-2022: Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
- Jul 19, 2022 · Class II · Z-1708-2022: Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- Jul 19, 2022 · Class II · Z-1706-2022: Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- Jul 19, 2022 · Class II · Z-1709-2022: Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- Jul 19, 2022 · Class II · Z-1707-2022: Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

## Indications for use
The Roadrunner® PC Wire Guide is used for catheter positioning and exchange in diagnostic and interventional procedures, exclusive of the coronary arteries.

Source page: https://510kreport.com/device/K182985
Methodology: https://510kreport.com/methodology