FDA 510(k)
FDA class 2
Substantially Equivalent
🇿🇦 South Africa
SAT CenterFlow Molding Balloon Catheter (IN20-00313)
K Number: K243184
·
Decision Jun 25, 2025
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
1
Review Days
268
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Basic Information
- Device Name
- SAT CenterFlow Molding Balloon Catheter (IN20-00313)
- K Number
- K243184
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Strait Access Technologies Holdings
- Date Received
- September 30, 2024
- Decision Date
- June 25, 2025
- 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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