FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Reprocessed BRK Transseptal Needle
K Number: K192998
·
Decision Jul 22, 2020
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
48
Review Days
268
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Basic Information
- Device Name
- Reprocessed BRK Transseptal Needle
- K Number
- K192998
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1390
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovative Health, LLC
- Date Received
- October 28, 2019
- Decision Date
- July 22, 2020
- Product Code
- NMK
- 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 |
|---|---|---|---|
| NMK | Trocar, Reprocessed | FDA class 2 | Cardiovascular |
Other Clearances by Innovative Health, LLC
| K Number | Device Name | ||
|---|---|---|---|
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