Identity
- Trade Name
- Ballast 088 Long Sheath FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide catheter/long sheath that is designed for facilitating the introduction of appropriately sized interventional devices into target blood vessels in the peripheral, coronary, and neuro vasculature. FDA UDI
- Model / Reference
- BALLAST105 FDA UDI
- Description
- The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide catheter/long sheath that is designed for facilitating the introduction of appropriately sized interventional devices into target blood vessels in the peripheral, coronary, and neuro vasculature. FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00840303712817 FDA UDI
- 510(k) Number
- K182918 FDA UDI
- FDA Product Code
- DQY 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
- Catheter Working Length — 105 Centimeter FDA UDICatheter Inner Diameter — 0.088 Inch FDA UDI
Category: Vascular guide-catheter, single-use
Ballast 088 Long Sheath 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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Cleared under the same submission
K182918 also covers:
- Ballast 088 Long Sheath — BALT USA LLC
- Ballast 088 Long Sheath — BALT USA LLC
- Ballast 088 Long Sheath — BALT USA LLC
- Ballast 088 Long Sheath — BALT USA LLC
- Ballast 088 Long Sheath — BALT USA LLC
- Ballast 088 Long Sheath — BALT USA LLC
- Ballast 088 Long Sheath — BALT USA LLC
- Ballast 088 Long Sheath — BALT USA LLC
- Ballast 088 Long Sheath — BALT USA LLC
- Ballast 088 Long Sheath — BALT USA LLC
- Ballast 088 Long Sheath — BALT USA LLC
- Ballast 088 Long Sheath — BALT USA LLC
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 3d3d02df-0f83-40c4-977c-0de57a5163cf 38 fields · synced May 30, 2026