510(k) K251383
- Device
- Prestige Coil System (Prestige Packing Line Extension)
- Applicant
- Balt USA, LLC
- 510(k) number
- K251383
- Product code
- KRD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-30
- Date received
- 2025-05-02
- Regulation
- 870.3300
- Classification name
- Device, Vascular, For Promoting Embolization
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kavita Chandrashekar
- Address
- 29 Parker Irvine CA US 92618 92618
FDA Registration Numbers#
- 2245304
- 2183870
- 2134265
- 3004091615
- 3000143502
- 3005580113
- 2011171
- 3030003849
- 3007029079
- 3005735987
- 3012536737
- 1000121056
- 3015453963
- 3009905888
- 2030624
- 3015615738
- 3033589330
- 2124215
- 2183744
- 3002124543
- 2133641
- 3015531723
- 3013353964
- 3009526575
- 3008307705
- 3027595249
- 2024024
- 9616662
- 3007113487
- 3012931345
- 1928237
- 3010079067
- 3012179728
- 3025434462
- 2030598
- 3015309643
- 3002807295
- 3031240343
- 3016688836
- 1531062
- 2024311
- 3013505221
- 3008853977
- 3008264254
- 3014162263
- 9614654
- 3010273872
- 1820334
- 3033841272
- 3010178296
- 3013944123
- 3007738736
- 3005168196
- 3005111382
- 3011137372
- 9616684
- 3002807314
- 3016609702
- 9610849
- 1225687
- 3008114965
- 3013758550
- 3015151147
- 3004859241
- 2135147
- 2029275
- 3009761573
- 3007628272
- 2032112
- 3002808486
- 3012448339
- 3042953152
- 3009380063
- 1721504
- 3008881809
- 3006950086
- 1721676
- 2184009
- 3008262715
- 3013556777
Source Documents#
Other 510(k) Records For Product Code KRD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260508 | LOBO Vascular Occlusion System | Okami Medical, Inc. | 2026-04-10 |
| K253511 | Concerto Versa™ Detachable Coil | Medtronic, Inc. | 2026-01-14 |
| K253677 | Tembo Embolic System | Instylla, Inc. | 2025-12-15 |
| K253376 | OBSIDIO™ Conformable Embolic (M0013972101010) | Boston Scientific Corporation | 2025-10-30 |
| K250209 | Polyvinyl Alcohol Embolic Microspheres | Canyon Medical, Inc. | 2025-09-23 |
| K250133 | HARBOR Occlusion Device | Nuvascular, Inc. | 2025-07-09 |
| K250971 | Embosphere Microspheres | Biosphere Medical, S.A. | 2025-05-16 |
| K250276 | Nitinol Enhanced Device (NED) | Embolization, Inc. | 2025-05-15 |
| K250079 | Ruby XL System | Penumbra, Inc. | 2025-03-14 |
| K242608 | Embozene Color-Advanced Microspheres | Varian Medical Systems, Inc. | 2025-01-17 |
| K240873 | TEMBO Embolic System | Instylla, Inc. | 2024-12-16 |
| K242794 | ONCOZENE Microspheres | Varian Medical Systems, Inc. | 2024-10-16 |
| K242507 | OBSIDIO™ Conformable Embolic | Boston Scientific | 2024-10-03 |
| K232934 | Sunsphere | Hangzhou Yangshun Medical Technology Co.,Ltd | 2024-05-30 |
| K240261 | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) | Merit Medical Systems, Inc. | 2024-05-02 |