Identity
- Trade Name
- AuST Steerable Sheath FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements. FDA UDI
- Model / Reference
- 0-085H-H1774SAN0-SNCP0 FDA UDI
- Description
- The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810024671236 FDA UDI
- 510(k) Number
- K242106 FDA UDI
- FDA Product Code
- DRA FDA UDIDYB FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1280 FDA UDI870.1340 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: Vascular guide-catheter, single-use
AuST Steerable Sheath by CenterPoint Systems 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
K242106 also covers:
- AuST Steerable Sheath — CenterPoint Systems LLC
- AuST Steerable Sheath — CenterPoint Systems LLC
- AuST Steerable Sheath — CenterPoint Systems LLC
- AuST Steerable Sheath — CenterPoint Systems LLC
- AuST Steerable Sheath — CenterPoint Systems LLC
- AuST Steerable Sheath — CenterPoint Systems LLC
- AuST Steerable Sheath — CenterPoint Systems LLC
- AuST Steerable Sheath — CenterPoint Systems LLC
- AuST Steerable Sheath — CenterPoint Systems LLC
- AuST Steerable Sheath — CenterPoint Systems LLC
- AuST Steerable Sheath — CenterPoint Systems LLC
- AuST Steerable Sheath — CenterPoint Systems 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
- CenterPoint Systems LLC
Sources (1)
- FDA UDI c2f86abc-556c-48bc-ae2b-1a2188d27705 34 fields · synced Jun 9, 2026