FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
BANTAM CATHETER (280MM BALLOON LENGTHS)
K Number: K112335
·
Decision Oct 12, 2011
Classifications
1
FEI Numbers
271
Registration Numbers
272
Same Product Code
880
Applicant Total
4
Review Days
61
Basic Information
- Device Name
- BANTAM CATHETER (280MM BALLOON LENGTHS)
- K Number
- K112335
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CLEAR STREAM TECHNOLOGIES, LTD.
- Date Received
- August 12, 2011
- Decision Date
- October 12, 2011
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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