# K963320: TFX Medical Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Tfx Medical Group
- Decided: Dec 3, 1996 after 102 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
Longest line of descent: 1 generation back to K770977 (1977). 20 ancestors in all.
103 later devices descend from it; 4 cite it directly.
7 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850677: Teleflex Guidewire, Teleflexmedical, Inc. (1985) Summary page 1.
- K860258: Teleflex Teflon Coated Guidewire, Teleflexmedical, Inc. (1986) Summary page 1.
- K871850: Teleflex Steerable Guidewire, Teleflexmedical, Inc. (1988) Summary page 1.
- K914531: Stainless Steel Gen Pur Interventional Guide Wires, Arrow Intl., Inc. (1992) Summary page 1.
- K924607: Arrow Fischell Kink Resist Percut Sheath Intro Set, Arrow Intl., Inc. (1993) Summary page 1.
- K841926: Hydroglide Spring Guide Wires, Argon Medical Corp. (1985) Summary page 1.
- K871297: Kadir HI-Torque Guide Wire, Argon Medical Corp. (1987) Summary page 1.
- K901899: Roadrunner Wire Guide, Cook, Inc. (1990) Summary page 1.
- K920824: Roadrunner RLTF Guide Wire, Cook, Inc. (1992) Summary page 1.
- K920891: Roadrunner (TM) Wire Guide, Modification, Cook, Inc. (1992) Summary page 1.
- K902152: Movable Core Guidewire, Guidewire Technologies, Inc. (1990) Summary page 1.
- K902153: Teflon Coated Guidewire, Guidewire Technologies, Inc. (1990)
- K770977: Cardiovascular Spring Guides, Lake Region Mfg., Inc. (1977) Summary page 1.
- K864058: Amplatz Moveable Core Guidewire, Lake Region Mfg., Inc. (1987) Summary page 1.
- K871882: Lake Region Variable Stiffness Guidewire (VSGW), Lake Region Mfg., Inc. (1987) Summary page 1.
- K901224: Insite Steerable Guidewire, Lake Region Mfg., Inc. (1990) Summary page 1.
- K914138: Ontrac, Lake Region Mfg., Inc. (1991) Summary page 1.
- K935170: Cardiovascular and Vascular Guidewire Modifications, Lake Region Mfg., Inc. (1994) Summary page 1.
- K935198: Gastroenterology and Urology Guidewire Modifications, Lake Region Mfg., Inc. (1994) Summary page 1.
- K941229: Ontrac Steerable Guidewire, Lake Region Mfg., Inc. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K924438: Arrow International Inc.. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.
- K521200: Lake Region Manufacturing. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- K012083: Attain Access 6218 Left-Heart Delivery System, Model 6218 (2001), 89 descendants of its own
- K013517: 10600 Deflectable Catheter System, Model 10600 (2002), 80 descendants of its own
- K032312: Attain 6226DEF Deflectable Catheter Delivery System (2003), 37 descendants of its own
- K033989: Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 (2004), 35 descendants of its own
- K021587: Attain LDS 6216A Left-Heart Delivery System, Model 6216A (2002), 31 descendants of its own

## Indications for use
TFX Medical Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel - excluding use in coronary arteries and in the neurovasculature.

Source page: https://510kreport.com/device/K963320
Methodology: https://510kreport.com/methodology