SCEPTER C OCCLUSION BALLOON CATHETER
FDA 510(k) clearance K110741 · decided 2011-09-29
Clearance details
- K-number
- K110741
- Device name
- SCEPTER C OCCLUSION BALLOON CATHETER
- Applicant
- MicroVention, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-16
- Decision date
- 2011-09-29
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- MJN
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tistin, CA, US
- Third-party review
- No
- Expedited review
- No
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| RenovoCath (K212324) | Renovorx, Inc. | 2021-08-23 |
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| Bridge Occlusion Balloon (K203540) | Spectranetics, Inc. | 2020-12-23 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Flow Re-Direction Endoluminal Device (FRED®) System (P180027/S013) | MicroVention, Inc. | 2025-11-02 |
| Flow Re-Direction Endoluminal Device (FRED) X System (P180027/S012) | MicroVention, Inc. | 2025-09-20 |
| FRED X System (P180027/S014) | MicroVention, Inc. | 2025-09-18 |
| Roadsaver/CASPER Carotid Stent Device (P210030/S001) | MicroVention, Inc. | 2025-06-23 |
| Roadsaver/CASPER Carotid Stent Device (P210030) | MicroVention, Inc. | 2024-11-20 |
| Woven EndoBridge Aneurysm Embolization (WEB) System (P170032/S017) | MicroVention, Inc. | 2024-09-23 |
| Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr (P170013/S012) | MicroVention, Inc. | 2024-08-21 |
| Flow Re-Direction Endoluminal Device (FRED®) System (P180027/S011) | MicroVention, Inc. | 2024-08-21 |