# K955293: Fibered Platinum Coil, .035 Type

- Pathway: 510(k) (Traditional)
- Applicant: Target Therapeutics
- Decided: Feb 6, 1996 after 82 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
192 later devices descend from it; 6 cite it directly.
1 of 193 devices in its family (counting itself) has 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
- K971395: Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid Coil, Fibered Platinum Coils, Acce (1997), 150 descendants of its own
- K991139: Guglielmi Detachable (GDC) (1999), 138 descendants of its own
- K993415: GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant Guglielmi Detachable Coil, GDC-1 (2000), 105 descendants of its own
- K022420: Micrus Stretch-Resistant Microcoil System, MSR01 (2002), 103 descendants of its own
- K993417: GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil (GDC) (3D Shape GDC) (2000), 98 descendants of its own

## Recalls of this device
- Jun 23, 2003 · Not classified · Z-1033-03: Product 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa
- Jun 23, 2003 · Not classified · Z-1034-03: Product 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa

Source page: https://510kreport.com/device/K955293
Methodology: https://510kreport.com/methodology