FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
LEV-OR DILATION CATHETER OTW
K Number: K101117
·
Decision Jul 16, 2010
Classifications
1
FEI Numbers
271
Registration Numbers
272
Same Product Code
880
Applicant Total
28
Review Days
86
Basic Information
- Device Name
- LEV-OR DILATION CATHETER OTW
- K Number
- K101117
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BAYLIS MEDICAL CO., INC.
- Date Received
- April 21, 2010
- Decision Date
- July 16, 2010
- 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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