FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters
K Number: K162625
·
Decision Jun 12, 2017
Classifications
1
FEI Numbers
76
Registration Numbers
76
Same Product Code
85
Applicant Total
3
Review Days
265
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Basic Information
- Device Name
- SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters
- K Number
- K162625
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- B. Braun Interventional Systems, Inc.
- Date Received
- September 20, 2016
- Decision Date
- June 12, 2017
- Product Code
- LOX
- 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 |
|---|---|---|---|
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | FDA class 2 | Cardiovascular |
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