FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
087 Balloon Guide Catheter System
K Number: K192525
·
Decision Oct 31, 2019
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
1
Review Days
48
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Basic Information
- Device Name
- 087 Balloon Guide Catheter System
- K Number
- K192525
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Q'Apel Medical, LLC
- Date Received
- September 13, 2019
- Decision Date
- October 31, 2019
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- 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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