NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
FDA 510(k) K200195 · Northeast Scientific, Inc.
510(k) numberK200195
Submission
- Device name
- NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
- Applicant
- Northeast Scientific, Inc.
Waterbury, CT, US - Received
- January 27, 2020
- Decision date
- June 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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| 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 |
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More from Philips Image Guided Therapy Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)OWQ · Traditional | 05/12/2025SE |
| K223026 | NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterOWQ · Traditional | 02/03/2023SE |
| K220171 | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterQTF · Traditional | 07/01/2022SE |
| K090661 | Nes Reprocessed Varicose Vein RF CatheterNUJ · Traditional | 07/21/2010SE |
| K060676 | Nes Reprocessed Endoscopic TrocarNLM · Traditional | 09/07/2007SE |
Questions and answers
When was NES Reprocessed Visions PV .014P RX Digital IVUS Catheter cleared by the FDA?
NES Reprocessed Visions PV .014P RX Digital IVUS Catheter (K200195) received a 510(k) decision of Substantially Equivalent on June 22, 2020, 147 days after the submission was received.
What is the product code of K200195?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.