Submission Details
| 510(k) Number | K250592 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 27, 2025 |
| Decision Date | May 12, 2025 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)
May 2025
Decision
74d
Days
Class 2
Risk
About This 510(k) Submission
K250592 is an FDA 510(k) clearance for the NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700), a Reprocessed Intravascular Ultrasound Catheter (Class II — Special Controls, product code OWQ), submitted by Northeast Scientific, Inc. (Waterbury, US). The FDA issued a Cleared decision on May 12, 2025, 74 days after receiving the submission on February 27, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.
Device Classification
| Product Code | OWQ — Reprocessed Intravascular Ultrasound Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1200 |
| Definition | For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology. |
Manufacturer
Similar Devices — OWQ Reprocessed Intravascular Ultrasound Catheter
All 29
K250545 · Surgical Instrument Service and Savings, Inc.
· Jun 2025
K243101 · Surgical Instrument Service and Savings, Inc.
· Mar 2025
K234064 · Surgical Instrument Service and Savings, Inc.
· Sep 2024
K232130 · Surgical Instrument Services and Savings, Inc.
· Dec 2023
K232584 · Vein 360, LLC
· Oct 2023
K230928 · Vein 360, LLC
· Aug 2023
More from Northeast Scientific, Inc.
View all
K223026
· OWQ · Feb 2023
K220171
· QTF · Jul 2022
K200195
· OBJ · Jun 2020
K090661
· NUJ · Jul 2010
K060676
· NLM · Sep 2007