# Boston Scientific Corporation (specification developer, Maple Grove, MN): 8 new FDA device listings, incl. catheter, continuous flush

**Score:** 95/100

| Field | Value |
|---|---|
| Establishment | Boston Scientific Corporation |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Maple Grove, MN, US |
| New listings | 8 |
| Devices | Catheter, Continuous Flush; System, Imaging, Pulsed Echo, Ultrasonic; Computer, Blood-Pressure; Computer, Diagnostic, Programmable; Transducer, Ultrasonic, Diagnostic; Catheter, Ultrasound, Intravascular; System, Image Processing, Radiological |
| Product codes | KRA, IYO, DSK, DQK, ITX, OBJ, LLZ |
| Device classes | Class II |
| Medical specialties | Cardiovascular, Radiology |
| First new listing | 2026-05-21 |
| Latest new listing | 2026-09-22 |
| FDA registration number | 2134265 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.