FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Highlander 014 PTA Balloon Dilatation Catheter
K Number: K223177
·
Decision Jan 20, 2023
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
399
Applicant Total
31
Review Days
101
Basic Information
- Device Name
- Highlander 014 PTA Balloon Dilatation Catheter
- K Number
- K223177
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- C.R. Bard, Inc.
- Date Received
- October 11, 2022
- Decision Date
- January 20, 2023
- Product Code
- LIT
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
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