FIBERED PLATINUM COIL, .035 TYPE
FDA 510(k) clearance K955293 · decided 1996-02-06
Clearance details
- K-number
- K955293
- Device name
- FIBERED PLATINUM COIL, .035 TYPE
- Applicant
- Target Therapeutics
- Decision
- Substantially Equivalent
- Date received
- 1995-11-16
- Decision date
- 1996-02-06
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- KRD
- Device class
- 2
- Regulation number
- 870.3300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Freemont, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Target Therapeutics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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
| Record | Firm | Date |
|---|---|---|
| Fibered Platinum Coil, 0.035 Type, 4 mm x 30 mm Catalog no. 372403 recall (Z-1033-03) | Boston Scientific Corporation | 2003-07-19 |
| Fibered Platinum Coil, 0.035 Type, 9 mm x 60 mm Catalog no. 372906 recall (Z-1034-03) | Boston Scientific Corporation | 2003-07-19 |