EMBOLIZATION COIL SYSTEM
FDA 510(k) clearance K992121 · decided 1999-12-20
Clearance details
- K-number
- K992121
- Device name
- EMBOLIZATION COIL SYSTEM
- Applicant
- Cook, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-06-23
- Decision date
- 1999-12-20
- Days to decision
- 180 days
- Clearance type
- Traditional
- Product code
- KRD
- Device class
- 2
- Regulation number
- 870.3300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bloomington, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UniPearls® Embolic Microspheres (K252812) | Suzhou Haowei Medical Technology Co., Ltd. | 2026-07-31 |
| OBSIDIO Conformable Embolic (K261488) | Boston Scientific Corporation | 2026-07-24 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| HARBOR Occlusion Device (K260635) | Nuvascular, Inc. | 2026-06-12 |
| LOBO Vascular Occlusion System (K260508) | Okami Medical, Inc. | 2026-04-10 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| Tembo Embolic System (K253677) | Instylla, Inc. | 2025-12-15 |
| OBSIDIO™ Conformable Embolic (M0013972101010) (K253376) | Boston Scientific Corporation | 2025-10-30 |
| Polyvinyl Alcohol Embolic Microspheres (K250209) | Canyon Medical, Inc. | 2025-09-23 |
| HARBOR Occlusion Device (K250133) | Nuvascular, Inc. | 2025-07-09 |
| Prestige Coil System (Prestige Packing Line Extension) (K251383) | Balt USA, LLC | 2025-05-30 |
| Embosphere Microspheres (K250971) | Biosphere Medical, S.A. | 2025-05-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Zenith® Iliac Branch (P020018/S064) | Cook, Inc. | 2025-05-30 |
| ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM (P020018/S065) | Cook, Inc. | 2025-04-09 |
| Zenith Fenestrated AAA Endovascular Graft (P020018/S063) | Cook, Inc. | 2024-04-29 |
| Zenith® Fenestrated AAA Endovascular Graft, Zenith® Flex AAA Endovascular System (P020018/S061) | Cook, Inc. | 2023-12-14 |
| Zenith® Fenestrated AAA Endovascular Graft (ZFEN), Zenith® Flex AAA Endovascular System (P020018/S062) | Cook, Inc. | 2023-12-13 |
| Zenith Fenestrated AAA Endovascular Graft (P020018/S060) | Cook, Inc. | 2022-01-20 |
| Zenith AAA Endovascular Graft (P020018/S059) | Cook, Inc. | 2020-10-08 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S055) | Cook, Inc. | 2018-10-10 |