FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EnSite X EP System
K Number: K242016
·
Decision Aug 9, 2024
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
57
Review Days
30
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Basic Information
- Device Name
- EnSite X EP System
- K Number
- K242016
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ABBOTT MEDICAL
- Date Received
- July 10, 2024
- Decision Date
- August 9, 2024
- Product Code
- DQK
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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Other Clearances by ABBOTT MEDICAL
| K Number | Device Name | ||
|---|---|---|---|
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| K260212 | EnSite X EP System | Apr 20, 2026 | Substantially Equivalent |
| K253907 | Disposable Radiofrequency Cannula | Apr 16, 2026 | Substantially Equivalent |
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| K252512 | Armada 14 NC PTA Catheter | Feb 13, 2026 | Substantially Equivalent |
| K253516 | Assert-IQ (DM5100) | Dec 18, 2025 | Substantially Equivalent |
| K252417 | Amplatzer Piccolo Delivery System (9-PDS-04F-045) | Dec 17, 2025 | Substantially Equivalent |
| K253232 | Seguin Annuloplasty Ring | Oct 29, 2025 | Substantially Equivalent |
| K250031 | Amplatzer Guidewire | Oct 3, 2025 | Substantially Equivalent |
| K252013 | EnSite X EP System | Sep 25, 2025 | Substantially Equivalent |