Identity
- Trade Name
- Edwards Lifesciences Vent Catheter FDA UDI
- Generic Name
- Chamber-decompression cardiac catheter FDA UDI
- Device Name
- Vent Catheter FDA UDI
- Model / Reference
- E061 FDA UDI
- Description
- Vent Catheter FDA UDI
Identifiers
- Catalog Number
- E061 FDA UDI
- Primary DI / UDI-DI
- 00690103030891 FDA UDI
- 510(k) Number
- K113411 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Chamber-decompression cardiac catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 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: Chamber-decompression cardiac catheter
Edwards Lifesciences Vent Catheter by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chamber-decompression cardiac catheter.
- Left Ventricle Vent with Obturator, with Side Holes — SORIN GROUP ITALIA SRL · Class II
- Left Atrium Vent with Obturator, with Side Holes — SORIN GROUP ITALIA SRL · Class II
- Edwards Lifesciences Vent Catheter — Edwards Lifesciences LLC · Class II
- Edwards Lifesciences Vent Catheter — Edwards Lifesciences LLC · Class II
- THRUPORT SYSTEMS ENDOVENT PULMONARY CATHETER KIT — Edwards Lifesciences LLC · Class II
Cleared under the same submission
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
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI e7fe1566-ba58-4f79-9e99-ea6e5546b267 37 fields · synced Jun 8, 2026