FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
K Number: K040447
·
Decision Mar 12, 2004
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
10
Applicant Total
432
Review Days
21
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Basic Information
- Device Name
- TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
- K Number
- K040447
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.4500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corp
- Date Received
- February 20, 2004
- Decision Date
- March 12, 2004
- Product Code
- LQC
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LQC | Lithotriptor, Biliary Mechanical | FDA class 2 | Gastroenterology, Urology |
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