FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Introcan Safety 3 Closed IV Catheter
K Number: K163358
·
Decision Apr 28, 2017
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
5
Review Days
149
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Basic Information
- Device Name
- Introcan Safety 3 Closed IV Catheter
- K Number
- K163358
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- B.Braun Melsungen AG
- Date Received
- November 30, 2016
- Decision Date
- April 28, 2017
- Product Code
- FOZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FOZ), ordered by most recent decision date.
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Other Clearances by B.Braun Melsungen AG
| K Number | Device Name | ||
|---|---|---|---|
| K152050 | Pencylcap | Mar 2, 2016 | Substantially Equivalent |
| K131040 | EXTAVIPRO STERICAN 30G | Jul 15, 2013 | Substantially Equivalent |
| K111236 | INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1 | Aug 30, 2011 | Substantially Equivalent |
| K102033 | COMBITRANS MONITORING SETS AND ACCESSORIES | Apr 7, 2011 | Substantially Equivalent |