Identity
- Trade Name
- Disposable Progressive Pressure Dilators FDA UDI
- Generic Name
- Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
- Device Name
- PPD Gastrointestinal Dilator 18-20mm Diameter x 8cm Length Balloon Dimension 200cm Total Catheter Length FDA UDI
- Model / Reference
- 1418 FDA UDI
- Description
- PPD Gastrointestinal Dilator 18-20mm Diameter x 8cm Length Balloon Dimension 200cm Total Catheter Length FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813353010127 FDA UDI
- 510(k) Number
- K020379 FDA UDI
- FDA Product Code
- KNT FDA UDIFGE FDA UDI
- GMDN Term
- Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI876.5010 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
No
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
Yes
FDA UDI
Category: Gastrointestinal/biliary dilation balloon catheter, non-medicated
Disposable Progressive Pressure Dilators by TeleMed Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal/biliary dilation balloon catheter, non-medicated.
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- Flex-Ez Stylet Wire Balloon Dilator — HOBBS MEDICAL, INC. · Class II
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Reliant(TM) Multistage Dilatation Balloon Catheter — Micro-Tech (Nanjing) Co., Ltd. · Class II
- MaxForce TTS — Boston Scientific · Class II
Cleared under the same submission
K020379 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
- TeleMed Systems
Sources (1)
- FDA UDI 4847ddfd-0d27-443f-a40a-4681b83b5e2c 34 fields · synced May 30, 2026