510(k) K203840
- Device
- BOSS 8F Balloon Guide Catheter
- Applicant
- Marblehead Medical LLC
- 510(k) number
- K203840
- Product code
- QJP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-01-28
- Date received
- 2020-12-31
- Regulation
- 870.1250
- Classification name
- Catheter, Percutaneous, Neurovasculature
- Medical specialty
- Cardiovascular
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kristin M. Mortenson
- Address
- 753 Fox Chase Rd. SW Rochester Mn MN US 55902 55902
FDA Registration Numbers#
- 1035166
- 3017636737
- 2027062
- 9617601
- 1064858
- 2024311
- 3008264254
- 2183744
- 3009546466
- 3004063494
- 3017210488
- 3011370111
- 3014779787
- 3000308637
- 1220477
- 3014590708
- 3014758755
- 3013656790
- 3015701715
- 3003780911
- 3014211783
- 3007007790
- 3017278832
- 3024801436
- 3020954126
- 3031768596
- 3025028711
- 3006451981
- 3027319104
- 3009965866
- 3014644549
- 3009057691
- 3002807314
- 3015550451
- 3019807891
- 3014162263
- 1721676
- 3007628272
- 3010079067
- 3030088112
- 3013758550
- 3005168196
- 3013858269
- 3016591327
- 3031311812
- 2029214
- 3015453963
- 3006010712
- 3009380063
- 3017168767
- 3008114965
- 3016800412
- 2030624
- 1047843
- 3014498720
- 3016522967
- 2011171
- 3009337401
- 3012497308
- 3008837339
- 3012543881
- 1048735
- 3013944123
- 3003775027
- 3032047719
- 3008881809
- 3008824097
- 3015615738
- 3008853977
- 3012931345
- 3013556777
Source Documents#
Other 510(k) Records For Product Code QJP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253359 | Zenith Distal Access Long Sheath | Suzhou Zenith Vascular SciTech Limited | 2026-05-22 |
| K254178 | SAYA 86 Radial Access Guide Catheter | Asahi Intecc Co., Ltd. | 2026-05-11 |
| K254046 | BosCATH Support Catheter | Sonorous NV, Inc. | 2026-04-21 |
| K254223 | Next Generation 088 Catheter | Balt USA, LLC | 2026-04-16 |
| K260938 | PATH BGC | Crossroads Neurovascular, Inc. | 2026-04-15 |
| K253975 | Radical 6F Access Catheter | Maduro Medical, Inc. | 2026-04-09 |
| K253032 | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | 2026-02-11 |
| K252297 | Toro 88 Superbore Catheter | Toro Neurovascular, Inc. | 2026-01-16 |
| K251097 | V-DAC Catheter | Vesalio, Inc. | 2026-01-06 |
| K251668 | SurfRider 13 Microcatheter | Kaneka Americas Holding, Inc. | 2026-01-05 |
| K252213 | Bendit17 Microcatheter | Bend IT Technologies, Ltd. | 2025-12-03 |
| K251372 | VersaD Delivery Catheter | Unity Medical, Inc. | 2025-10-24 |
| K252569 | Carrier XL Delivery Catheter | Balt USA, LLC | 2025-10-22 |
| K250960 | DUO Microcatheter | Rev Neuro, LLC | 2025-09-08 |
| K251560 | FUBUKI XF-R Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | 2025-06-20 |
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