Identity
- Trade Name
- Argyle FDA UDI
- Generic Name
- Peritoneal dialysis catheter, acute/chronic FDA UDI
- Device Name
- Dialysis Catheter Accessory,Dilator,10 Fr/Ch (3.3 mm), 15 cm FDA UDI
- Model / Reference
- 8815642001 FDA UDI
- Description
- Dialysis Catheter Accessory,Dilator,10 Fr/Ch (3.3 mm), 15 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521004009 FDA UDI
- 510(k) Number
- K862288 FDA UDI
- FDA Product Code
- DRE FDA UDI
- GMDN Term
- Peritoneal dialysis catheter, acute/chronic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Dimensions & Sizes
- Size
- Length — 15 Centimeter FDA UDICatheter Gauge — 10 French FDA UDI
Category: Peritoneal dialysis catheter, acute/chronic
Argyle by Mozarc Medical US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peritoneal dialysis catheter, acute/chronic.
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- I-SERIES PD Catheter — MEDICAL COMPONENTS INC · Class II
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- Peritoneal Dialysis Catheter — Medionics International , Ltd. · Class II
Cleared under the same submission
K862288 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
- Mozarc Medical US LLC
Sources (1)
- FDA UDI c7e0794e-e912-44e4-91eb-cffc8a7af34d 36 fields · synced Jun 8, 2026