FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRIMPORT
K Number: K945250
·
Decision Mar 7, 1995
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
287
Applicant Total
8
Review Days
130
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Basic Information
- Device Name
- TRIMPORT
- K Number
- K945250
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gerard Medical Enterprises, Inc.
- Date Received
- October 28, 1994
- Decision Date
- March 7, 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 Gerard Medical Enterprises, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954258 | TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) | May 24, 1996 | Substantially Equivalent |
| K942623 | TRIMPORT | Aug 23, 1994 | Substantially Equivalent |
| K922147 | DUAL PLASTIC VASCULAR ACCESS SYSTEM | Dec 4, 1992 | Substantially Equivalent |
| K913114 | TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT | Jan 2, 1992 | Unknown |
| K912111 | MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE | Oct 8, 1991 | Substantially Equivalent |
| K903364 | GERARD MEDICAL, INC. TRIM-PORT | Oct 31, 1990 | Unknown |
| K813358 | GERARD MEDICAL ELECTRODE TESTER | Dec 29, 1981 | Substantially Equivalent |