Identity
- Trade Name
- MITRACLIP FDA UDI
- Generic Name
- Heart valve clip FDA UDI
- Device Name
- MitraClip G4 Clip Delivery System XTW FDA UDI
- Model / Reference
- CDS0701-XTW FDA UDI
- Description
- MitraClip G4 Clip Delivery System XTW FDA UDI
Identifiers
- Catalog Number
- CDS0701-XTW FDA UDI
- Primary DI / UDI-DI
- 08717648231001 FDA UDI
- FDA Product Code
- NKM FDA UDI
- GMDN Term
- Heart valve clip 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Heart valve clip
Mitraclip by Abbott Vascular — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heart valve clip.
- TriClip™ — ST. JUDE MEDICAL, INC. · Class III
- PASCAL — Edwards Lifesciences LLC · Class III
- MitraClip™ — ST. JUDE MEDICAL, INC. · Class III
- TriClip™ — ST. JUDE MEDICAL, INC. · Class III
- MitraClip™ — ST. JUDE MEDICAL, INC. · Class III
- PASCAL — Edwards Lifesciences LLC · Class III
- TriClip™ — ST. JUDE MEDICAL, INC. · Class III
- TriClip™ — ST. JUDE MEDICAL, INC. · Class III
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 |
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Manufacturer
- Manufacturer
- Abbott Vascular
Sources (1)
- FDA UDI a782b14e-6702-4675-a303-c4fed3a1cac1 36 fields · synced May 30, 2026