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Biosense Webster Inc

⚠️ Moderate Risk

FEI: 2020638 • Baldwin Park, CA • UNITED STATES

FEI

FEI Number

2020638

📍

Location

Baldwin Park, CA

🇺🇸
🏢

Address

5110 Commerce Dr, , Baldwin Park, CA, United States

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
5/3/2002
Latest Refusal
2/7/2002
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

3413×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5083×

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
5/3/2002
79GCCDILATOR, CATHETER
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)
2/7/2002
79GCCDILATOR, CATHETER
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)
2/7/2002
79GCCDILATOR, CATHETER
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Biosense Webster Inc's FDA import refusal history?

Biosense Webster Inc (FEI: 2020638) has 3 FDA import refusal record(s) in our database, spanning from 2/7/2002 to 5/3/2002.

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. Biosense Webster Inc's FEI number is 2020638.

What types of violations has Biosense Webster Inc received?

Biosense Webster Inc has been cited for 2 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 Biosense Webster Inc come from?

All FDA import refusal data for Biosense Webster Inc 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.