Identity
- Trade Name
- Axiom® PVC FDA UDI
- Generic Name
- Pleural catheter FDA UDI
- Device Name
- Thoracic Catheter, Right Angle PVC FDA UDI
- Model / Reference
- 511140 FDA UDI
- Description
- Thoracic Catheter, Right Angle PVC FDA UDI
Identifiers
- Primary DI / UDI-DI
- M6655111400 FDA UDI
- 510(k) Number
- K841593 FDA UDI
- FDA Product Code
- GBS FDA UDI
- GMDN Term
- Pleural catheter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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: Pleural catheter
Axiom® PVC by Axiom Medical, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pleural catheter.
- Wayne — COOK INCORPORATED · Class II
- PLEUR-EVAC — TELEFLEX INCORPORATED · Class I
- Rocket — Rocket Medical Plc · Class I
- PLEUR-EVAC — TELEFLEX INCORPORATED · Class I
- PLEUR-EVAC — TELEFLEX INCORPORATED · Class I
- PVC Thoracic Catheters — Atrium Medical Corp. · Class I
- Silicone Thoracic Drain, S Type — FORTUNE MEDICAL INSTRUMENT CORP. · Class I
- Wayne — COOK INCORPORATED · Class II
Cleared under the same submission
K841593 also covers:
- Axiom® PVC — AXIOM MEDICAL, INCORPORATED
- Axiom® PVC — AXIOM MEDICAL, INCORPORATED
- Axiom® PVC — AXIOM MEDICAL, INCORPORATED
- Axiom® PVC — AXIOM MEDICAL, INCORPORATED
- Axiom® PVC — AXIOM MEDICAL, INCORPORATED
- Axiom® PVC — AXIOM MEDICAL, INCORPORATED
- Axiom® PVC — AXIOM MEDICAL, INCORPORATED
- Axiom® PVC — AXIOM MEDICAL, INCORPORATED
- Axiom® PVC — AXIOM MEDICAL, INCORPORATED
- Axiom® PVC — AXIOM MEDICAL, INCORPORATED
- Axiom® PVC — AXIOM MEDICAL, INCORPORATED
- Axiom® PVC — AXIOM MEDICAL, INCORPORATED
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 I | Pending data |
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Manufacturer
- Manufacturer
- Axiom Medical, Incorporated
Sources (1)
- FDA UDI ca00606c-feb3-47d9-96cc-d83ecde0e8c3 36 fields · synced May 30, 2026