FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771
K Number: K960391
·
Decision Jul 3, 1996
Classifications
1
FEI Numbers
437
Registration Numbers
437
Same Product Code
1167
Applicant Total
11
Review Days
156
Basic Information
- Device Name
- STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771
- K Number
- K960391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STRATO/INFUSAID, INC.
- Date Received
- January 29, 1996
- Decision Date
- July 3, 1996
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by STRATO/INFUSAID, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K953529 | STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM | Jan 26, 1996 | Substantially Equivalent |
| K954720 | STRATO/INFUSAIF INFUSE-A-CATH CENTRAL VENOUS CATHETERS | Jan 4, 1996 | Substantially Equivalent |
| K953254 | STRATO/INFUSAID INFUSE-A-KIT | Nov 29, 1995 | Unknown |
| K953256 | STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN PREATTACHED SILICONE CENTRAL VENOUS CATHETER SYSTEMS | Oct 4, 1995 | Substantially Equivalent |
| K953436 | STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL VENOUS CATHETER SYSTESM | Oct 4, 1995 | Substantially Equivalent |
| K950987 | STRATO/INFUSAID TUNNELER | Jun 2, 1995 | Substantially Equivalent |
| K951875 | STRATO/INFUSAID BUTTON PORT VASCULAR ACC. SYSTEM | May 24, 1995 | Substantially Equivalent |
| K951873 | STRATO/INFUSAIND MICROPORT VASCULAR ACC. SYSTEM | May 19, 1995 | Substantially Equivalent |
| K951874 | STRATO/INFUSAID MACROPORT VASCULAR ACC. SYSTEM | May 19, 1995 | Substantially Equivalent |
| K951872 | STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM | May 18, 1995 | Substantially Equivalent |