# K973708: Tomcat Guide Wire, Extender Wire, Guide Wire Extension Tool

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Dec 19, 1997 after 81 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) ACS Hi Torque™ 3 cm Extra S’Port Guide Wire: named in the summary without a submission number
- (no number) ACS Hi Torque™ 30 cm Standard Guide Wire: named in the summary without a submission number
- (no number) ACS Hi Torque™ 30 cm Floppy Guide Wire: named in the summary without a submission number
- (no number) SciMed Sceptor™ 3 cm Floppy Guide Wire: named in the summary without a submission number
- (no number) SciMed Sceptor™ 2 cm Standard Guide Wire: named in the summary without a submission number
- (no number) ACS DOC™ Guide Wire Extension 145 cm: named in the summary without a submission number

## Indications for use
The TomCat™ Guide Wire is intended to facilitate the placement of interventional catheters during therapeutic intravascular procedures. The TomCat Extender™ Wire is used to facilitate exchange of one therapeutic-device for another, while still maintaining the guide wire position in the coronary vasculature. The guide wire extension tool is a device used to facilitate the joining of a guide wire with an extension wire.

Source page: https://510kreport.com/device/K973708
Methodology: https://510kreport.com/methodology