Identity
- Trade Name
- ThromboWire FDA UDI
- Generic Name
- Thrombectomy wire-net FDA UDI
- Device Name
- The MegaVac Thrombectomy System is a single-use intravascular mechanical thrombectomy and aspiration system including a ThromboWire containing an embolectomy element. The MegaVac Catheter’s SafeSealTM technology utilizes a distal silicone coated nitinol braid that expands to temporarily occlude antegrade blood flow. The catheter body has inner and outer coaxial shafts that expand the braid, temporarily occluding the vessel and allowing for aspiration. The proximal handle assembly actuates the SafeSeal funnel. The ThromboWire consists of a nitinol embolectomy element that when expanded by the proximal actuation handle, can serve to pull matter towards the MegaVac catheter. FDA UDI
- Model / Reference
- ATK FDA UDI
- Description
- The MegaVac Thrombectomy System is a single-use intravascular mechanical thrombectomy and aspiration system including a ThromboWire containing an embolectomy element. The MegaVac Catheter’s SafeSealTM technology utilizes a distal silicone coated nitinol braid that expands to temporarily occlude antegrade blood flow. The catheter body has inner and outer coaxial shafts that expand the braid, temporarily occluding the vessel and allowing for aspiration. The proximal handle assembly actuates the SafeSeal funnel. The ThromboWire consists of a nitinol embolectomy element that when expanded by the proximal actuation handle, can serve to pull matter towards the MegaVac catheter. FDA UDI
Identifiers
- Catalog Number
- TWA FDA UDI
- Primary DI / UDI-DI
- B251TWA1 FDA UDI
- 510(k) Number
- K040010 FDA UDI
- FDA Product Code
- DXE FDA UDI
- GMDN Term
- Thrombectomy wire-net FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5150 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
Category: Thrombectomy wire-net
ThromboWire by Capture Vascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thrombectomy wire-net.
- Solitaire™ X-PACK — Micro Therapeutics, Inc. · Class II
- Solitaire™ X — Micro Therapeutics, Inc. · Class II
- ClotTriever XL Catheter — Inari Medical, Inc. · Class II
- Solitaire™ X-PACK — Micro Therapeutics, Inc. · Class II
- pRESET® Thrombectomy Device (4mm x 20mm) — PHENOX LIMITED · Class II
- Solitaire™ X — Micro Therapeutics, Inc. · Class II
- Solitaire™ X — Micro Therapeutics, Inc. · Class II
- Solitaire™ X-PACK — Micro Therapeutics, Inc. · Class II
Cleared under the same submission
K040010 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
- Capture Vascular, Inc.
Sources (1)
- FDA UDI 06e1f660-d6dd-4c47-a5da-61ad3bb5c51f 35 fields · synced Jun 8, 2026