FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE
K Number: K132943
·
Decision Aug 29, 2014
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
50
Applicant Total
3
Review Days
344
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Basic Information
- Device Name
- INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE
- K Number
- K132943
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1390
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synaptic Medical Limited
- Date Received
- September 19, 2013
- Decision Date
- August 29, 2014
- Product Code
- DRC
- 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 |
|---|---|---|---|
| DRC | Trocar | FDA class 2 | Cardiovascular |
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