FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
NRG TRANSSEPTAL NEEDLE
K Number: K073326
·
Decision May 28, 2008
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
16
Applicant Total
28
Review Days
183
Basic Information
- Device Name
- NRG TRANSSEPTAL NEEDLE
- K Number
- K073326
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5175
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BAYLIS MEDICAL CO., INC.
- Date Received
- November 27, 2007
- Decision Date
- May 28, 2008
- Product Code
- DXF
- 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 |
|---|---|---|---|
| DXF | Catheter, Septostomy | FDA class 2 | Cardiovascular |
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