Identity
- Trade Name
- Pruitt Occlusion Catheter FDA UDI
- Generic Name
- Intravascular occluding balloon catheter, image-guided FDA UDI
- Device Name
- Pruitt Occlusion Catheter, 3F, eIFU FDA UDI
- Model / Reference
- e2103-36 FDA UDI
- Description
- Pruitt Occlusion Catheter, 3F, eIFU FDA UDI
Identifiers
- Catalog Number
- e2103-36 FDA UDI
- Primary DI / UDI-DI
- 00840663101580 FDA UDI
- 510(k) Number
- K811276 FDA UDI
- FDA Product Code
- DYG FDA UDI
- GMDN Term
- Intravascular occluding balloon catheter, image-guided FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1240 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
Yes
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: Intravascular occluding balloon catheter, image-guided
Pruitt Occlusion Catheter by LeMaitre Vascular, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intravascular occluding balloon catheter, image-guided.
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- LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CATHETER — LUCAS MEDICAL INC · Class II
- HyperFormTM — Micro Therapeutics, Inc. · Class II
- CELLO™, Balloon Guide Catheter — Fuji Systems Corp. · Class II
- TAPAS® Catheter — Thermopeutix, Inc. · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
Sources (2)
- FDA UDI 178e52e2-6553-427b-893a-05d8786e63f6 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026