FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IDEAS' DUAL PORT
K Number: K962751
·
Decision Sep 30, 1996
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
287
Applicant Total
15
Review Days
77
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Basic Information
- Device Name
- IDEAS' DUAL PORT
- K Number
- K962751
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ideas For Medicine, Inc.
- Date Received
- July 15, 1996
- Decision Date
- September 30, 1996
- 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 Ideas For Medicine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961883 | VERSA-CATH ARTERIAL CATHETER | Jan 13, 1997 | Substantially Equivalent |
| K961716 | VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE | Sep 19, 1996 | Substantially Equivalent |
| K960715 | PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F | Sep 9, 1996 | Substantially Equivalent |
| K960422 | PRUITT SAFETY OCCLUSION CATHETER | Aug 7, 1996 | Substantially Equivalent |
| K954713 | DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION) | Jul 24, 1996 | Substantially Equivalent |
| K935964 | IDEAS OCCLUDER | Jan 4, 1995 | Substantially Equivalent |
| K935023 | GODAT UTERINE MANIPULATOR INJECTOR | Jan 4, 1995 | Substantially Equivalent |
| K880231 | MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER | May 25, 1988 | Substantially Equivalent |
| K872090 | THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT | Oct 30, 1987 | Substantially Equivalent |
| K872485 | CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY) | Aug 12, 1987 | Substantially Equivalent |