FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach
K Number: K251211
·
Decision May 23, 2025
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
77
Applicant Total
57
Review Days
35
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Basic Information
- Device Name
- ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach
- K Number
- K251211
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ABBOTT MEDICAL
- Date Received
- April 18, 2025
- Decision Date
- May 23, 2025
- Product Code
- OBJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OBJ | Catheter, Ultrasound, Intravascular | FDA class 2 | Cardiovascular |
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| K Number | Device Name | ||
|---|---|---|---|
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| K252512 | Armada 14 NC PTA Catheter | Feb 13, 2026 | Substantially Equivalent |
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| K253232 | Seguin Annuloplasty Ring | Oct 29, 2025 | Substantially Equivalent |
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