Reconnaissance PV .018 OTW Digital IVUS Catheter
FDA 510(k) K200410 · Philips Image Guided Therapy Corporation
510(k) numberK200410
Submission
- Device name
- Reconnaissance PV .018 OTW Digital IVUS Catheter
- Applicant
- Philips Image Guided Therapy Corporation
San Diego, CA, US - Received
- February 19, 2020
- Decision date
- May 22, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K252945 | Novasight Hybrid SystemOBJ · Traditional | Conavi Medical, Inc. | 04/17/2026SE |
| K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter…OBJ · Special | Boston Scientific | 04/08/2026SE |
| K253399 | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterOBJ · Special | Volcano Corporation (Dba Philips Image Guided… | 10/28/2025SE |
| 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 |
| K251211 | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid…OBJ · Special | Abbott Medical | 05/23/2025SE |
| 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 |
More from Philips Image Guided Therapy Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K253714 | IntraSight PlusIYO · Traditional | 02/24/2026SE |
| K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac…OBJ · Special | 05/09/2025SE |
| K200812 | VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE CatheterOBJ · Traditional | 09/02/2020SE |
Questions and answers
When was Reconnaissance PV .018 OTW Digital IVUS Catheter cleared by the FDA?
Reconnaissance PV .018 OTW Digital IVUS Catheter (K200410) received a 510(k) decision of Substantially Equivalent on May 22, 2020, 93 days after the submission was received.
What is the product code of K200410?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.