← Back to catalogue
PipelineTM Flex Embolization Device with Shield TechnologyTM
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- PipelineTM Flex Embolization Device with Shield TechnologyTM FDA UDI
- Generic Name
- Bare-metal intracranial vascular stent FDA UDI
- Device Name
- STENT PED2-425-30 V06 E-IFU FDA UDI
- Model / Reference
- PED2-425-30 FDA UDI
- Description
- STENT PED2-425-30 V06 E-IFU FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000284473 FDA UDI
- PMA Number
- P100018 FDA UDI
- FDA Product Code
- OUT FDA UDI
- GMDN Term
- Bare-metal intracranial vascular stent FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Bare-metal intracranial vascular stent
PipelineTM Flex Embolization Device with Shield TechnologyTM by Micro Therapeutics, Inc. — Class III — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Bare-metal intracranial vascular stent.
- Comaneci Petit — RAPID MEDICAL INC. · Class II
- Surpass Elite — Stryker Corp. · Class III
- Surpass Elite — Stryker Corp. · Class III
- Surpass Elite — Stryker Corp. · Class III
- Neuroform Atlas — Stryker Corp. · Class III
- LVIS — MICROVENTION INC. · Unclassified
- Surpass Streamline — Stryker Corp. · Class III
- LVIS Junior — MICROVENTION INC. · Unclassified
Cleared under the same submission
P100018 also covers:
- PIPELINE — Micro Therapeutics, Inc.
- PIPELINE — Micro Therapeutics, Inc.
- PIPELINE — Micro Therapeutics, Inc.
- PIPELINE — Micro Therapeutics, Inc.
- PIPELINE — Micro Therapeutics, Inc.
- PIPELINE — Micro Therapeutics, Inc.
- PIPELINE — Micro Therapeutics, Inc.
- PIPELINE — Micro Therapeutics, Inc.
- PIPELINE — Micro Therapeutics, Inc.
- PIPELINE — Micro Therapeutics, Inc.
- PIPELINE — Micro Therapeutics, Inc.
- PIPELINE — Micro Therapeutics, 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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micro Therapeutics, Inc.
Sources (1)
- FDA UDI 16521469-4088-489b-90b9-05d322ff6175 36 fields · synced May 30, 2026