510(k) K100063
- Device
- HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL
- Applicant
- EV3 INC
- 510(k) number
- K100063
- Product code
- MJN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-02-02
- Date received
- 2010-01-11
- Regulation
- 870.4450
- Classification name
- Catheter, Intravascular Occluding, Temporary
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Laura Heaton
- Address
- 9775 Toledo Way Irvine CA US 92618 92618
FDA Registration Numbers#
- 1721676
- 3026788751
- 3011279674
- 3007284313
- 3032916632
- 1018233
- 3013556777
- 9616684
- 3005994106
- 3007113487
- 1220948
- 2011171
- 3012279212
- 3002807314
- 3000126629
- 3010079067
- 3009766315
- 3012159165
- 3012179728
- 3008816935
- 3016842760
- 9681260
- 1928237
- 2029386
- 3008837339
- 3018565086
- 3011660785
- 1319639
- 3008114965
- 2528981
- 3010432890
- 3004859241
- 3009756153
- 2135147
- 9618000
- 3008853977
- 3005255160
- 3008627763
- 3014162263
- 2029214
- 3007628272
- 1000121056
- 3007284006
- 2032112
- 3010173425
- 3015138222
- 1318694
- 3006082230
- 1724474
- 3016257349
- 3013944123
- 8023054
- 3016704395
- 3015550451
- 1048735
- 2183982
- 2124215
- 3008881809
- 3012497308
- 2183744
- 2648045
- 1424778
Source Documents#
Other 510(k) Records For Product Code MJN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243795 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | 2025-09-05 |
| K251358 | Bridge Plus Occlusion Balloon (590-002) | Philips Image Guided Therapy Devices | 2025-06-24 |
| K221294 | preCARDIA Occlusion System | Abiomed, Inc. | 2023-06-30 |
| K214060 | LANDMARK REBOA Catheter | Zien Medical Technologies, Inc. | 2022-09-19 |
| K211610 | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | 2022-02-14 |
| K212324 | RenovoCath | Renovorx, Inc. | 2021-08-23 |
| K210602 | AortaSTAT Occlusion Device | Renalpro Medical, Inc. | 2021-07-09 |
| K210358 | Neurescue device | Neurescue Aps | 2021-05-21 |
| K201652 | COBRA-OS Kit | Front Line Medical Technologies, Inc. | 2021-02-22 |
| K203540 | Bridge Occlusion Balloon | Spectranetics, Inc. | 2020-12-23 |
| K200459 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | 2020-06-03 |
| K192786 | Gatekeeper Balloon Catheter | Arch Catheter, LLC | 2020-04-25 |
| K193440 | ER-REBOA PLUS Catheter | Prytime Medical Devices, Inc. | 2020-01-09 |
| K191606 | RenovoCath | Renovorx, Inc. | 2019-08-07 |
| K183045 | Eclipse 2L | Balt USA, LLC | 2019-04-30 |
Legacy Summary#
summary
FDA Review#
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