FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NC TREK OTW CORONARY DILATATION CATHETER
K Number: K113464
·
Decision Mar 6, 2012
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
81
Applicant Total
25
Review Days
105
Basic Information
- Device Name
- NC TREK OTW CORONARY DILATATION CATHETER
- K Number
- K113464
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Vascular
- Date Received
- November 22, 2011
- Decision Date
- March 6, 2012
- 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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