FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Hereaeus Poseidon Microcatheter
K Number: K191305
·
Decision Dec 19, 2019
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
174
Applicant Total
4
Review Days
219
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Basic Information
- Device Name
- Hereaeus Poseidon Microcatheter
- K Number
- K191305
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heraeus Medical Components, LLC
- Date Received
- May 14, 2019
- Decision Date
- December 19, 2019
- Product Code
- KRA
- 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 |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | FDA class 2 | Cardiovascular |
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