# K030617: PT2 Guide Wire and Addwire Extension Wire

- Pathway: 510(k) (Abbreviated)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: May 21, 2003 after 84 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K913353 (1991). 19 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962572: Scimed Choice PT Vision Ptca Guide Wire, Scimed Life Systems, Inc. (1996) Summary page 1.
- K021228: HI-Torque Balance, Balance Middleweight, Balance Heavyweight, Balance Trek and the Balance Middleweight Universal Guide, Guidant Corp. (2002)
- K983033: Acs HT Balance Middleweight Guide Wire, Guidant Corp. (1998) Summary page 1.
- K973494: HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque Balance Middleweight Guide Wire with Hydg, Guidant Corp. (1997) Summary page 1.
- K971815: Asc Balance Middleweight Guide Wire, Guidant Corp. (1997) Summary page 1.
- K970376: Ptca Guidewire, Lake Region Mfg., Inc. (1997) Summary page 1.
- K011968: Streerable Ptca Guidewire, Lake Region Mfg., Inc. (2001)

## Most influential descendants
- K143587: ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire (2015), 6 descendants of its own
- K032183: IQ Hydrophilic Guide Wire (2003), 4 descendants of its own
- K040140: IQ Guide Wire (2004), 3 descendants of its own
- K152231: Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire (2016), 2 descendants of its own
- K081021: Kinetix Guidewire, Plus Guidewire (2008), 1 descendant of its own

## Recalls of this device
- Aug 31, 2006 · Not classified · Z-1540-06: The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip.
- Aug 31, 2006 · Not classified · Z-1538-06: The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip.
- Aug 31, 2006 · Not classified · Z-1541-06: The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip.
- Aug 31, 2006 · Not classified · Z-1539-06: The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip.

## Indications for use
The PT2TMGuide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. The PT2TMGuide Wires are not intended for use in the cerebral vasculature. The AddWireTMExtension Wire creates an extended guide wire that can be used to exchange out a therapeutic device without removing the original guide wire from the anatomy. When the exchange is complete, the Extension Wire can be detached and the original guide wire can be used in a conventional manner.

Source page: https://510kreport.com/device/K030617
Methodology: https://510kreport.com/methodology