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Sign in to claim this brandInstylla, Inc.
United States·US-MF-000021019
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 201, Burlington Rd, Bedford, United States
- Website
- instylla.com
- —
- —
- [email protected]
- Phone
- 781-790-4860
- PRRC Contact
- Amita Shah
- EUDAMED SRN
- US-MF-000021019
- FDA FEI Number
- 3017208642
- DUNS Number
- 081009360
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Instylla Microcatheter 1.2 | INS90-2001-007 | FDA UDI | Class II | Active |
| Instylla Microcatheter | INS90-2001-005 | FDA UDI | Class II | Active |
| Instylla Microcatheter 1.2 | INS90-2001-009 | FDA UDI | Class II | Active |
| Instylla Microcatheter | INS90-2001-004 | FDA UDI | Class II | Active |
| Instylla Microcatheter 1.2 | INS90-2001-008 | FDA UDI | Class II | Active |
| Instylla Delivery Kit | INS90-3001-007 | FDA UDI | Class II | Active |
| Instylla Microcatheter | INS90-2001-006 | FDA UDI | Class II | Active |
| Instylla Microcatheter | K191731 | FDA 510(k) | Class II | Active |
| Instylla Microcatheter 1.2 | K210808 | FDA 510(k) | Class II | Active |
| Tembo Embolic System | K253677 | FDA 510(k) | Class II | Active |
| TEMBO Embolic System | K240873 | FDA 510(k) | Class II | Active |
| Instylla Microcatheter | K200744 | FDA 510(k) | Class II | Active |
| Embrace Hydrogel Embolic System (HES) | P250003 | FDA PMA | Class III | Active |
| Instylla Delivery Kit | INS90-3001-009 | EUDAMEDFDA UDI | Class I | Active |
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