GEL-BEAD EMBOLIZATION SPHERES
FDA 510(k) clearance K133237 · decided 2014-04-25
Clearance details
- K-number
- K133237
- Device name
- GEL-BEAD EMBOLIZATION SPHERES
- Applicant
- Vascular Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-10-21
- Decision date
- 2014-04-25
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- KRD
- Device class
- 2
- Regulation number
- 870.3300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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| Tembo Embolic System (K253677) | Instylla, Inc. | 2025-12-15 |
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| Polyvinyl Alcohol Embolic Microspheres (K250209) | Canyon Medical, Inc. | 2025-09-23 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Duett Sealing Device (D-Stat Flowable) (P990037/S036) | Vascular Solutions, Inc. | 2022-11-04 |
| Duett Sealing Device (P990037/S035) | Vascular Solutions, Inc. | 2021-07-13 |
| D-Stat Flowable hemostat (P990037/S034) | Vascular Solutions, Inc. | 2016-10-05 |
| D-STAT FLOWABLE HEMOSTAT (P990037/S032) | Vascular Solutions, Inc. | 2016-02-25 |
| VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S031) | Vascular Solutions, Inc. | 2010-09-15 |
| VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S030) | Vascular Solutions, Inc. | 2010-05-07 |
| D-STAT FLOWABLE HEMOSTAT (P990037/S029) | Vascular Solutions, Inc. | 2009-12-02 |
| DUETT PRO SEALING DEVICE, MODEL 1010 (P990037/S028) | Vascular Solutions, Inc. | 2008-12-17 |