FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFE-CONNECT VIAL DISPENSING SPIKE
K Number: K970789
·
Decision May 1, 1997
Classifications
1
FEI Numbers
176
Registration Numbers
176
Same Product Code
200
Applicant Total
6
Review Days
58
Basic Information
- Device Name
- SAFE-CONNECT VIAL DISPENSING SPIKE
- K Number
- K970789
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- FAULDING MEDICAL DEVICE CO.
- Date Received
- March 4, 1997
- Decision Date
- May 1, 1997
- Product Code
- LHI
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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Other Clearances by FAULDING MEDICAL DEVICE CO.
| K Number | Device Name | ||
|---|---|---|---|
| K962159 | STERILE AMBULATORY RESERVOIR 60ML/100ML | Jul 18, 1997 | Substantially Equivalent |
| K970909 | SAFE-CONNECT I.V. SET | May 6, 1997 | Substantially Equivalent |
| K971266 | SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518 | May 1, 1997 | Substantially Equivalent |
| K970524 | SAFE-CONNECT I.V. EXTENSION SET | Apr 22, 1997 | Substantially Equivalent |
| K955775 | SAFECONNECT VALVE (CATALOG NO. XXXX) | Nov 15, 1996 | Substantially Equivalent |