FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Occlusion Perfusion Catheter
K Number: K151554
·
Decision Sep 15, 2015
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
70
Applicant Total
3
Review Days
98
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Basic Information
- Device Name
- Occlusion Perfusion Catheter
- K Number
- K151554
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Advanced Catheter Therapies, Inc.
- Date Received
- June 9, 2015
- Decision Date
- September 15, 2015
- Product Code
- QEY
- 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 |
|---|---|---|---|
| QEY | Mechanical Thrombolysis Catheter | FDA class 2 | Cardiovascular |
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