FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
aeris Balloon Dialation Catheter
K Number: K150951
·
Decision Jun 25, 2015
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
32
Applicant Total
3
Review Days
77
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Basic Information
- Device Name
- aeris Balloon Dialation Catheter
- K Number
- K150951
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bryan Medical, Inc.
- Date Received
- April 9, 2015
- Decision Date
- June 25, 2015
- Product Code
- KTI
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KTI | Bronchoscope Accessory | FDA class 2 | Ear, Nose, Throat |
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