Identity
- Trade Name
- PleuraFlow® System with FlowGlide FDA UDI
- Generic Name
- Closed-wound drain, non-bioabsorbable FDA UDI
- Device Name
- PFFG-28 RA PleuraFlow® System with FlowGlide FDA UDI
- Model / Reference
- PFFG-28 RA FDA UDI
- Description
- PFFG-28 RA PleuraFlow® System with FlowGlide FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856449006123 FDA UDI
- 510(k) Number
- K163139 FDA UDI
- FDA Product Code
- OTK FDA UDI
- GMDN Term
- Closed-wound drain, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 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
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 28 French FDA UDI
Category: Closed-wound drain, non-bioabsorbablePleural catheterMediastinal drainage catheter, non-antimicrobial
PleuraFlow® System with FlowGlide by Clearflow, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mediastinal drainage catheter, non-antimicrobial.
- Flexima™ APD™ — Boston Scientific · Class II
- Thoraguard — Centese, Inc. · Class I
- Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATED · Class I
- MedDrain — ARMM INC. · Class I
- Flexima™ APDL — Boston Scientific · Class II
- Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATED · Class I
- Flexima™ Quickstick™ — Boston Scientific · Class II
- Thoracic Drain — LivaNova USA, Inc. · Class I
Cleared under the same submission
K163139 also covers:
- PleuraFlow® System with FlowGlide — CLEARFLOW, INC
- PleuraFlow® System with FlowGlide — CLEARFLOW, INC
- PleuraFlow® System with FlowGlide — CLEARFLOW, INC
- PleuraFlow® System with FlowGlide — CLEARFLOW, INC
- PleuraFlow® System with FlowGlide — CLEARFLOW, INC
- PleuraFlow® System with FlowGlide — CLEARFLOW, INC
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
- Clearflow, Inc
Sources (1)
- FDA UDI 19284513-24f3-4848-9b7c-adc8d3713f50 37 fields · synced May 29, 2026