Instylla Microcatheter
FDA 510(k) clearance K191731 · decided 2019-08-13
Clearance details
- K-number
- K191731
- Device name
- Instylla Microcatheter
- Applicant
- Instylla, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-06-28
- Decision date
- 2019-08-13
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- KRA
- Device class
- 2
- Regulation number
- 870.1210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Embrace Hydrogel Embolic System (HES) (P250003/S002) | Instylla, Inc. | 2025-12-17 |
| Embrace(TM) Hydrogel Embolic System (P250003/S001) | Instylla, Inc. | 2025-11-25 |
| Embrace(TM) Hydrogel Embolic System (P250003) | Instylla, Inc. | 2025-08-05 |