# K121398: Charlie Guidewire (Regular), Charlie Guidewire (Stiff)

- Pathway: 510(k) (Traditional)
- Applicant: Guidepath Medical, Inc.
- Decided: Dec 13, 2012 after 218 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 12 (12 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K913353 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863138: Terumo Radifocus Guide Wire, Terumo Medical Corp. (1986). Our reading of the summary gave K863168, FDA’s number for Model 1101M & 1151M Urolab Micro Urodynamic Record (Life-Tech Intl., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Terumo - Radifocus Guidewire”.
- K841926: Hydroglide Spring Guide Wires, Argon Medical Corp. (1985) Summary page 1.
- K101011: HI-Torque Balance Middleweight Universal, Abbott Vascular, Inc. (2010)

## Recalls of this device
- May 28, 2014 · Class I · Z-1823-2014: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
- May 28, 2014 · Class I · Z-1821-2014: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
- May 28, 2014 · Class I · Z-1818-2014: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
- May 28, 2014 · Class I · Z-1820-2014: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
- May 28, 2014 · Class I · Z-1817-2014: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
- May 28, 2014 · Class I · Z-1815-2014: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
- May 28, 2014 · Class I · Z-1813-2014: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
- May 28, 2014 · Class I · Z-1816-2014: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
- May 28, 2014 · Class I · Z-1819-2014: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
- May 28, 2014 · Class I · Z-1814-2014: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
- May 28, 2014 · Class I · Z-1822-2014: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
- May 28, 2014 · Class I · Z-1812-2014: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

## Indications for use
To facilitate the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventionial procedures.

Source page: https://510kreport.com/device/K121398
Methodology: https://510kreport.com/methodology