Identity
- Trade Name
- Symphony™ Advance™ Long Dilator FDA UDI
- Generic Name
- Thrombectomy suction catheter FDA UDI
- Device Name
- 24F Symphony™ Advance™ Long Dilator FDA UDI
- Model / Reference
- ADVANCE FDA UDI
- Description
- 24F Symphony™ Advance™ Long Dilator FDA UDI
Identifiers
- Catalog Number
- ADVANCE FDA UDI
- Primary DI / UDI-DI
- 00850032079174 FDA UDI
- FDA Product Code
- QEW FDA UDIKRA FDA UDI
- GMDN Term
- Thrombectomy suction catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5150 FDA UDI870.1210 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
- Introducer Sheath Compatibility — 24 French FDA UDI
Category: Thrombectomy suction catheter
Symphony™ Advance™ Long Dilator by Imperative Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thrombectomy suction catheter.
- Indigo System — PENUMBRA, INC. · Class II
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- Trevo — Stryker Corp.
- Penumbra System — PENUMBRA, INC. · Class II
- Pounce ™ Thrombectomy — Surmodics, Inc. · Class II
- Solitaire™ — Micro Therapeutics, Inc. · Class II
- Stroke Fast Pack — Stryker Corp.
- Indigo System — PENUMBRA, INC. · Class II
Cleared under the same submission
K223216 also covers:
K250775 also covers:
K252057 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 |
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Manufacturer
- Manufacturer
- Imperative Care Inc.
Sources (1)
- FDA UDI b02ddee4-21cd-4978-90f5-c9bb02c3ac5a 38 fields · synced May 29, 2026