# K010497: Silverspeed Hydrophilic Guidewire, Models 103-0601-300 and 103-0602-300

- Pathway: 510(k) (Special)
- Applicant: Micro Therapeutics, Inc.
- Decided: Mar 22, 2001 after 29 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K010497
Methodology: https://510kreport.com/methodology