FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LF CT HIG PRESSURE CATHETERS
K Number: K945053
·
Decision May 19, 1995
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
27
Review Days
217
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Basic Information
- Device Name
- LF CT HIG PRESSURE CATHETERS
- K Number
- K945053
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mallinckrodt Group, Inc.
- Date Received
- October 14, 1994
- Decision Date
- May 19, 1995
- 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 |
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Other Clearances by Mallinckrodt Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K945140 | URO-FLO | Mar 8, 1995 | Substantially Equivalent |
| K943581 | HYDRADJUST IV UROLOGICAL TABLE | Jan 4, 1995 | Substantially Equivalent |
| K943122 | SURGICAL DRAPES | Sep 7, 1994 | Substantially Equivalent |
| K934664 | HYDRAGOWN | May 24, 1994 | Substantially Equivalent |
| K920742 | HYDRAJUST IV UROLOGICAL TABLE | Apr 27, 1992 | Substantially Equivalent |
| K912944 | CT 8000 DIGITAL INJECTION SYSTEM | Feb 4, 1992 | Substantially Equivalent |
| K913264 | HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE | Nov 1, 1991 | Substantially Equivalent |
| K905789 | FRANKLIN 9000 WALL STAND | May 20, 1991 | Substantially Equivalent |
| K904147 | HUGH YOUNG II UROLOGICAL X-RAY SYSTEM | Dec 13, 1990 | Substantially Equivalent |
| K904145 | HYDRA VISION UROLOGICAL X-RAY SYSTEM | Dec 13, 1990 | Substantially Equivalent |