Retracta Detachable Embolization Coil
FDA 510(k) K123712 · Cook Incorporated
510(k) numberK123712
Submission
- Device name
- Retracta Detachable Embolization Coil
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- December 4, 2012
- Decision date
- January 3, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRD – Device, Vascular, For Promoting Embolization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3300
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code KRD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252812 | UniPearls® Embolic MicrospheresKRD · Traditional | Suzhou Haowei Medical Technology Co., Ltd. | 07/31/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | Boston Scientific Corporation | 07/24/2026SE |
| K261866 | Concerto Versa Detachable CoilKRD · Special | Medtronic, Inc. | 06/24/2026SE |
| K260635 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 06/12/2026SE |
| K260508 | LOBO Vascular Occlusion SystemKRD · Traditional | Okami Medical, Inc. | 04/10/2026SE |
| K253511 | Concerto Versa Detachable CoilKRD · Traditional | Medtronic, Inc. | 01/14/2026SE |
| K253677 | Tembo Embolic SystemKRD · Special | Instylla, Inc. | 12/15/2025SE |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010)KRD · Special | Boston Scientific Corporation | 10/30/2025SE |
| K250209 | Polyvinyl Alcohol Embolic MicrospheresKRD · Traditional | Canyon Medical, Inc. | 09/23/2025SE |
| K250133 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 07/09/2025SE |
More from Nuvascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233177 | Nest VT Vitrification DeviceMQK · Traditional | 03/08/2024SE |
| K222254 | Gunther Tulip Vena Cava Filter Retrieval SetMMX · Traditional | 05/16/2023SE |
| K223098 | Bakri Essential Postpartum BalloonOQY · Special | 10/28/2022SE |
| K210734 | Endovascular Dilator and SetsDRE · Special | 04/06/2021SE |
| K203670 | Extra Large Check-Flo IntroducerDYB · Traditional | 02/16/2021SE |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…LJE · Traditional | 01/29/2020SESK |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture SetLJE · Traditional | 12/16/2019SE |
| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…JOH · Special | 12/12/2019SE |
| K191163 | Lumax Guiding CatheterDQY · Traditional | 12/12/2019SE |
| K190084 | McLean-Ring Enteral Feeding Tube SetKNT · Traditional | 10/11/2019SE |
Questions and answers
When was Retracta Detachable Embolization Coil cleared by the FDA?
Retracta Detachable Embolization Coil (K123712) received a 510(k) decision of Substantially Equivalent on January 3, 2013, 30 days after the submission was received.
What is the product code of K123712?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.