FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Chocolate PTA Balloon Catheter
K Number: K213631
·
Decision Dec 15, 2021
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
209
Review Days
28
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Basic Information
- Device Name
- Chocolate PTA Balloon Catheter
- K Number
- K213631
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- November 17, 2021
- Decision Date
- December 15, 2021
- 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 |
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