FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
DISCOGRAPHY KIT
K Number: K910503
·
Decision Oct 7, 1991
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
6
Applicant Total
19
Review Days
244
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Basic Information
- Device Name
- DISCOGRAPHY KIT
- K Number
- K910503
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1730
- Medical Specialty
- Radiology
- Decision
- Unknown
- Applicant
- B. Braun of America, Inc.
- Date Received
- February 5, 1991
- Decision Date
- October 7, 1991
- Product Code
- IZG
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IZG | System, X-Ray, Photofluorographic | FDA class 2 | Radiology |
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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 |
| K945752 | CELSITE(TM) BRACHIAL VENOUS PORT | May 31, 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 |