# K982543: Silverstreak Hydrophilic Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc.
- Decided: Dec 11, 1998 after 143 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices 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) Dasher-10 Guidewire: named in the summary without a submission number
- (no number) B. Braun Guidewire Introducer: named in the summary without a submission number
- (no number) Transend-10 Guidewire: named in the summary without a submission number
- (no number) B. Braun Guidewire Torque Device: named in the summary without a submission number

## Most influential descendants
- K124007: Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange Guidewire, X-Pedion Hydrophilic Guidewire, Mirage HY (2013), 2 descendants of its own
- K193548: Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire (2020), 1 descendant of its own
- K201690: Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire (2020), 0 descendants of its own
- K994141: Catheter, Intravascular Occluding, Temporary, Model Sol 3510; Wire, Guide, Catheter, Model QSW1000 (2000), 0 descendants of its own

## Recalls of this device
- Apr 5, 2007 · Not classified · Z-0839-2007: Two customer complaints were received from physicians in Japan indicating the hydrophilic coating was observed flaking from the guidewire while immersed in hydrating media following use during aneurys

## Indications for use
The SilverSpeed guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

Source page: https://510kreport.com/device/K982543
Methodology: https://510kreport.com/methodology