Identity
- Trade Name
- EchelonTM FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- 105-5091-150 ECHELON 10 MICRO CATHETER FDA UDI
- Model / Reference
- 105-5091-150 FDA UDI
- Description
- 105-5091-150 ECHELON 10 MICRO CATHETER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847536005969 FDA UDI
- 510(k) Number
- K093750 FDA UDI
- FDA Product Code
- KRA FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Vascular guide-catheter, single-use
EchelonTM by Micro Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vascular guide-catheter, single-use.
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- Mach1™ — Boston Scientific · Class II
- SHERPA NX BALANCED — MEDTRONIC, INC. · Class II
Cleared under the same submission
K093750 also covers:
- Echelon — Micro Therapeutics, Inc.
- Echelon — Micro Therapeutics, Inc.
- Echelon — Micro Therapeutics, Inc.
- Echelon — Micro Therapeutics, Inc.
- Echelon — Micro Therapeutics, Inc.
- Echelon — Micro Therapeutics, Inc.
- EchelonTM — Micro Therapeutics, Inc.
- EchelonTM — Micro Therapeutics, Inc.
- EchelonTM — Micro Therapeutics, Inc.
- EchelonTM — Micro Therapeutics, Inc.
- EchelonTM — Micro Therapeutics, Inc.
- Marathon — Micro Therapeutics, Inc.
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
- Micro Therapeutics, Inc.
Sources (1)
- FDA UDI b83529c7-d935-43dd-84b2-5acf01b2d7ff 36 fields · synced May 31, 2026