# K113412: Target Detachable Coil

- Pathway: 510(k) (Special)
- Applicant: Stryker Neurovascular
- Decided: Dec 13, 2011 after 25 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 28 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K951256 (1995). 36 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093142: Target Detachable Coils and Inzone Detachment System, Boston Scientific Corp (2010) Summary page 2.
- K102672: Target Detachable Coil, Boston Scientific Corp (2010) Summary page 2.
- K112385: Traget Detachable Coil, Stryker Neurovascular (2011)

## Most influential descendants
- K123377: Target Detachable Coil (2012), 12 descendants of its own
- K153658: Target Detachable Coils (2016), 11 descendants of its own
- K161429: Target Detachable Coils (2016), 10 descendants of its own
- K222533: Target Tetra Detachable Coils (2022), 3 descendants of its own
- K203625: Numen Coil Embolization System; NumenFR Detachment System (2021), 3 descendants of its own

## Recalls of this device
- Jun 6, 2016 · Class II · Z-2171-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2179-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2175-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2167-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2168-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2184-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2180-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2164-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2186-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2177-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2163-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2165-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2172-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2170-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2173-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2160-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2182-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2183-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2176-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2161-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2187-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2181-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2178-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2185-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2169-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2174-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2162-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam
- Jun 6, 2016 · Class II · Z-2166-2016: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been dam

## Indications for use
Target Detachable Coils are indicated for the endovascular embolization of: - Intracranial aneurysms - Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae - Arterial and venous embolizations in the peripheral vasculature

Source page: https://510kreport.com/device/K113412
Methodology: https://510kreport.com/methodology