FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CELSITE(TM) BRACHIAL VENOUS PORT
K Number: K945752
·
Decision May 31, 1995
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
287
Applicant Total
19
Review Days
189
Basic Information
- Device Name
- CELSITE(TM) BRACHIAL VENOUS PORT
- K Number
- K945752
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- B. Braun of America, Inc.
- Date Received
- November 23, 1994
- Decision Date
- May 31, 1995
- Product Code
- LJT
- 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 |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by B. Braun of America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993024 | CELSITE IMPLANTABLE PORT WITH VALVED CATHETER | Mar 13, 2000 | Substantially Equivalent |
| K983794 | CHEMO MINI SPIKE PLUS | Mar 23, 1999 | Substantially Equivalent |
| K946170 | COMFORT-Q SUBCUTANEOUS INJECTION SETS | Nov 3, 1995 | Substantially Equivalent |
| K945850 | BRAUN DIACAN(R) FISTULA NEEDLES | Oct 6, 1995 | Substantially Equivalent |
| K942988 | FILTERED EXTENSION SETS | Jul 14, 1995 | Substantially Equivalent |
| K945551 | CELSITE(TM) DUAL VENOUS SYSTEM | Apr 21, 1995 | Substantially Equivalent |
| K943770 | LOW VOLUME MULTIPORT | Apr 10, 1995 | Substantially Equivalent |
| K950982 | B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE | Apr 4, 1995 | Substantially Equivalent |
| K950184 | B. BRAUN IV START KITS | Mar 15, 1995 | Unknown |
| K943181 | DISPENSING PIN WITH ONE-WAY VALVE | Sep 29, 1994 | Substantially Equivalent |