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
FDA 510(k) K251211 · Abbott Medical
510(k) numberK251211
Submission
- 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
- Applicant
- Abbott Medical
Plymouth, MN, US - Received
- April 18, 2025
- Decision date
- May 23, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
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| K261696 | ACUNAV Luxera 4D ICE CatheterOBJ · Special | Siemens Medical Solutions USA, Inc. | 09/10/2026SE |
| K261849 | VERAFEYE Imaging Catheter (VF-VIC-002)OBJ · Special | Luma Vision Limited | 07/24/2026SE |
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| K250955 | XC11 ICE System, USAOBJ · Traditional | Yorlabs, Inc. | 10/22/2025SE |
| K250913 | TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemOBJ · Traditional | Jiangsu Tingsn Technology Co., Ltd. | 07/19/2025SE |
| K251231 | ViewFlex X ICE Catheter, Sensor EnabledOBJ · Special | Abbott Medical | 05/20/2025SE |
| K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac…OBJ · Special | Philips Image Guided Therapy Corporation | 05/09/2025SE |
| K242893 | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemOBJ · Traditional | Luma Vision Limited | 03/24/2025SE |
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Questions and answers
When was 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 cleared by the FDA?
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 (K251211) received a 510(k) decision of Substantially Equivalent on May 23, 2025, 35 days after the submission was received.
What is the product code of K251211?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.