Identity
- Trade Name
- Halo One™ Thin-Walled Guiding Sheath FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- Halo One 4F guiding sheath diameter, 70 cm shaft length, including 035 Dilator with hydrophilic coating FDA UDI
- Model / Reference
- HLO47035 FDA UDI
- Description
- Halo One 4F guiding sheath diameter, 70 cm shaft length, including 035 Dilator with hydrophilic coating FDA UDI
Identifiers
- Catalog Number
- HLO47035 FDA UDI
- Primary DI / UDI-DI
- 00801741161858 FDA UDI
- 510(k) Number
- K192313 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 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
Yes
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
Halo One™ Thin-Walled Guiding Sheath by ClearStream Technologies , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular guide-catheter, single-use.
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- Surefire Guiding Catheter — Surefire Medical, Inc. · Class II
- SHERPA NX BALANCED™ — MEDTRONIC, INC. · Class II
- Zebra — QApel Medical, Inc. · Class II
- Mach1™ — Boston Scientific · Class II
- SHERPA NX BALANCED — MEDTRONIC, INC. · Class II
Cleared under the same submission
K192313 also covers:
- Halo One™ Thin-Walled Guiding Sheath — ClearStream Technologies , Ltd.
- Halo One™ Thin-Walled Guiding Sheath — ClearStream Technologies , Ltd.
- Halo One™ Thin-Walled Guiding Sheath — ClearStream Technologies , Ltd.
- Halo One™ Thin-Walled Guiding Sheath — ClearStream Technologies , Ltd.
- Halo One™ Thin-Walled Guiding Sheath — ClearStream Technologies , Ltd.
- Halo One™ Thin-Walled Guiding Sheath — ClearStream Technologies , Ltd.
- Halo One™ Thin-Walled Guiding Sheath — ClearStream Technologies , Ltd.
- Halo One™ Thin-Walled Guiding Sheath — ClearStream Technologies , Ltd.
- Halo One™ Thin-Walled Guiding Sheath — ClearStream Technologies , Ltd.
- Halo One™ Thin-Walled Guiding Sheath — ClearStream Technologies , Ltd.
- Halo One™ Thin-Walled Guiding Sheath — ClearStream Technologies , Ltd.
- Halo One™ Thin-Walled Guiding Sheath — ClearStream Technologies , Ltd.
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
- ClearStream Technologies , Ltd.
Sources (1)
- FDA UDI 606097c2-474b-4840-9edd-f504853c928e 36 fields · synced Jun 6, 2026