510(k) K171747
- Device
- MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL
- Applicant
- Codman & Shurtleff, Inc.
- 510(k) number
- K171747
- Product code
- HCG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-07-14
- Date received
- 2017-06-13
- Regulation
- 882.5950
- Classification name
- Device, Neurovascular Embolization
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Vivian Perez
- Address
- 325 Paramount Dr. Raynham MA US 02767 02767
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#
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#
summary
FDA Review#
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