FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WATCHMAN TruSteer Access System (M635TU90050)
K Number: K240018
·
Decision Feb 1, 2024
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
231
Review Days
30
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Basic Information
- Device Name
- WATCHMAN TruSteer Access System (M635TU90050)
- K Number
- K240018
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- January 2, 2024
- Decision Date
- February 1, 2024
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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