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MEGA Ballast Distal Access Platform
FDA UDIClass II (US FDA UDI)
by Balt Usa Llc
Identity
- Trade Name
- MEGA Ballast Distal Access Platform FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- MEGA Ballast Distal Access Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. FDA UDI
- Model / Reference
- MEGABT09190 FDA UDI
- Description
- MEGA Ballast Distal Access Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00840303711797 FDA UDI
- 510(k) Number
- K242376 FDA UDI
- FDA Product Code
- DQY FDA UDIQJP FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.108 Centimeter FDA UDI
Category: Vascular guide-catheter, single-use
MEGA Ballast Distal Access Platform by Balt Usa Llc — 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
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Cleared under the same submission
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
- Balt Usa Llc
Sources (1)
- FDA UDI 2d01a0fe-2b4c-4b16-954c-97effbdcf66b 38 fields · synced May 30, 2026