Berenstein Coil
FDA 510(k) K964112 · Target Therapeutics
510(k) numberK964112
Submission
- Device name
- Berenstein Coil
- Applicant
- Target Therapeutics
Freemont, CA, US - Received
- October 15, 1996
- Decision date
- February 26, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K965071 | Detachable Slicone Balloon (DSB)MZQ · Traditional | 04/21/1998SE |
| K964488 | Detachable Silicone Balloon (DSB)MZQ · Traditional | 04/21/1998SE |
| K964210 | Retriever IIDQO · Traditional | 10/31/1997SE |
| K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…DQX · Traditional | 07/14/1997SE |
| K965189 | SpinnakerKRA · Traditional | 03/24/1997SE |
| K963307 | GDC Patient Return Electtrode Model 45021HCG · Traditional | 12/17/1996SE |
| K962503 | Guglielmi Detachable CoilHCG · Traditional | 09/20/1996SE |
| K961923 | Berenstein CoilHCG · Traditional | 08/15/1996SE |
| K960705 | Guglielmi Detachable CoilHCG · Traditional | 05/21/1996SE |
| K960806 | Turbo TrackerDQO · Traditional | 05/02/1996SE |
Questions and answers
When was Berenstein Coil cleared by the FDA?
Berenstein Coil (K964112) received a 510(k) decision of Substantially Equivalent on February 26, 1997, 134 days after the submission was received.
What is the product code of K964112?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.