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Boston Scientific Corporation

⚠️ Moderate Risk

FEI: 1000116179 • Minnetonka, MN • UNITED STATES

FEI

FEI Number

1000116179

📍

Location

Minnetonka, MN

🇺🇸
🏢

Address

10700 Bren Rd W, , Minnetonka, MN, United States

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
10/24/2001
Latest Refusal
10/24/2001
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
10/24/2001
79GCCDILATOR, CATHETER
508NO 510(K)
New York District Office (NYK-DO)

Frequently Asked Questions

What is Boston Scientific Corporation's FDA import refusal history?

Boston Scientific Corporation (FEI: 1000116179) has 1 FDA import refusal record(s) in our database, spanning from 10/24/2001 to 10/24/2001.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Boston Scientific Corporation's FEI number is 1000116179.

What types of violations has Boston Scientific Corporation received?

Boston Scientific Corporation has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Boston Scientific Corporation come from?

All FDA import refusal data for Boston Scientific Corporation is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.