# K992121: Embolization Coil System

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Dec 20, 1999 after 180 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951256 (1995). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940189: Coil Positioner Set, Cook, Inc. (1994). Our OCR of the scanned summary read K942189, FDA’s number for Crystal Ear (Crystal Care Intl., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Embolization Coil Positioner Set”.
- K901337: Hilal Embolization Microcoil (TM), Cook, Inc. (1990) Summary page 2.
- K951256: Detachable Platinum Coil (Guglielmi Detachable Coil, GDC), Target Therapeutics (1995) Summary page 2.
- K960705: Guglielmi Detachable Coil, Target Therapeutics (1996) Summary page 2.
- K955293: Fibered Platinum Coil, .035 Type, Target Therapeutics (1996) Summary page 2.

## Most influential descendants
- K123712: Retracta Detachable Embolization Coil (2013), 3 descendants of its own
- K151676: Retracta Detachable Embolization Coil (2015), 2 descendants of its own
- K160219: Hilal Embolization MicroCoils (2016), 0 descendants of its own
- K153778: Nester Embolization Coils, Tornado Embolization Coils (2016), 0 descendants of its own

## Indications for use
Arterial and venous embolization in the peripheral vasculature

Source page: https://510kreport.com/device/K992121
Methodology: https://510kreport.com/methodology