Identity
- Trade Name
- Instylla Microcatheter 1.2 FDA UDI
- Generic Name
- Vascular microcatheter FDA UDI
- Device Name
- N/A FDA UDI
- Model / Reference
- INS90-2001-007 FDA UDI
- Description
- N/A FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00812013030086 FDA UDI
- 510(k) Number
- K210808 FDA UDI
- FDA Product Code
- KRA FDA UDI
- GMDN Term
- Vascular microcatheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1210 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 122 Centimeter FDA UDI
Category: Vascular microcatheter
Instylla Microcatheter 1.2 by Instylla, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular microcatheter.
- Velocity Delivery Microcatheter — PENUMBRA, INC. · Class II
- Knight Microcatheter — ZIEN Medical Technologies, LLC · Class II
- Merit Pursue™ — Merit Medical Systems, Inc. · Class I
- Renegade™ HI-FLO™ Kit — Boston Scientific · Class II
- PROWLER — Medos International Sàrl · Class II
- Merit Maestro® — Merit Medical Systems, Inc. · Class II
- Lantern Delivery Catheter — PENUMBRA, INC. · Class II
- Direxion™ Fathom™-16 System — Boston Scientific · Class II
Cleared under the same submission
K210808 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Instylla, Inc.
Sources (1)
- FDA UDI db26fa55-f1e3-4655-b348-15281ad8507c 37 fields · synced May 30, 2026