510(k) K080967
- Device
- TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT
- Applicant
- CORDIS NEUROVASCULAR, INC.
- 510(k) number
- K080967
- Product code
- HCG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-05-02
- Date received
- 2008-04-04
- Regulation
- 882.5950
- Classification name
- Device, Neurovascular Embolization
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Amarilys Machado
- Address
- 14201 NW 60th Ave. Miami Lakes FL US 33014 33014
FDA Registration Numbers#
- 3031550970
- 3007029079
- 3006950086
- 3005168196
- 1225687
- 9615728
- 1220477
- 3010173425
- 1043729
- 3012543881
- 3013758550
- 3013556777
- 3015615738
- 3008837339
- 3015453963
- 3016540856
- 2029214
- 3016609702
- 9616684
- 3033589330
- 3012931345
- 2134265
- 3003524171
- 2022435
- 3000143502
- 1721676
- 3008264254
- 3002807295
- 3014162263
- 2029275
- 3016591327
- 3009761573
- 3015550451
- 3008824097
- 3008307705
- 9617601
- 3007628272
- 3010079067
- 9614654
- 2030598
- 1226348
- 3016245399
- 3012536737
- 1820334
- 3002124543
- 3027595249
- 3017961114
- 3008114965
- 2126666
- 3010178296
- 2124215
- 2011171
- 3008853977
- 3009380063
- 3008881809
- 3013353964
- 3015531723
- 3013944123
- 2133641
- 3015309643
- 3014644549
- 3007738736
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HCG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260351 | Numen™ Helia Coil Embolization System; NumenFR™ Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2026-05-20 |
| K254221 | Optima Coil System (OptiOne Coil System) | Balt USA, LLC | 2026-01-27 |
| K252694 | Target Detachable Coil | Stryker Neurovascular | 2025-12-11 |
| K251832 | InZone IST Detachment System; IZDS Connecting Cable | Stryker Neurovascular | 2025-10-17 |
| K252700 | Optima Coil System (Optima Packing Coil System) | Balt USA, LLC | 2025-09-26 |
| K242154 | Numen™ Coil Embolization System; NumenFR™ Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024-09-30 |
| K242582 | Optima Coil System (OptiBlock Line Extension) | Balt USA, LLC | 2024-09-27 |
| K242243 | Target Detachable Coils | Stryker Neurovscular | 2024-08-29 |
| K232955 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024-01-10 |
| K233420 | Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2023-11-07 |
| K230284 | Penumbra LP Coil System | Penumbra, Inc. | 2023-10-25 |
| K222533 | Target Tetra Detachable Coils | Stryker Neurovascular | 2022-12-14 |
| K223386 | Optima Coil System | Balt USA, LLC | 2022-12-06 |
| K220040 | CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems | Medos International SARL | 2022-07-14 |
| K212455 | InZone Detachment System | Stryker Neurovascular | 2021-11-16 |
Legacy Summary#
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FDA Review#
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