510(k) K914786
- Device
- TARGET THERAPEUTICS COILS
- Applicant
- TARGET THERAPEUTICS
- 510(k) number
- K914786
- Product code
- KRD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-04-20
- Date received
- 1991-10-23
- Regulation
- 870.3300
- Classification name
- Device, Vascular, For Promoting Embolization
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GRACE BRORS
- Address
- 130 Rio Robles P.O. Box 610458 San Jose CA US 95134 95134
FDA Registration Numbers#
- 3016591327
- 3031550970
- 3030003849
- 1225687
- 1423662
- 3008307705
- 9616662
- 3005168196
- 3015225571
- 2030598
- 3002808486
- 1424778
- 3009761573
- 9616684
- 3012120143
- 9615728
- 2183870
- 3005111382
- 3014162263
- 2133641
- 2245304
- 3042953152
- 3015550451
- 3007628272
- 3015453963
- 3013944123
- 2024311
- 3007029079
- 1721676
- 1220477
- 3015309643
- 3016245399
- 3005580113
- 3012536737
- 3007113487
- 3043869342
- 3010178296
- 3013353964
- 2183744
- 2134265
- 3009526575
- 3012448339
- 3044156918
- 9610849
- 1820334
- 3009380063
- 2953359
- 3015151147
- 9681260
- 3015615738
- 3010173425
- 2030624
- 3008837339
- 1048735
- 3012276280
- 9614654
- 2124215
- 3002807295
- 3031240343
- 3012931345
- 2024024
- 3033841272
- 3010273872
- 3004859241
- 3033589330
- 2029214
- 3008262715
- 1928237
- 9617601
- 2184009
- 2011171
- 3017961114
- 3012179728
- 1000393132
- 3008264254
- 3008881809
- 3008853977
- 3013556777
- 3016609702
Source Documents#
Other 510(k) Records For Product Code KRD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252812 | UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. | 2026-07-31 |
| K261488 | OBSIDIO Conformable Embolic | Boston Scientific Corporation | 2026-07-24 |
| K261866 | Concerto Versa™ Detachable Coil | Medtronic, Inc. | 2026-06-24 |
| K260635 | HARBOR Occlusion Device | Nuvascular, Inc. | 2026-06-12 |
| 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 |
| K251383 | Prestige Coil System (Prestige Packing Line Extension) | Balt USA, LLC | 2025-05-30 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases