FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
I.V. FILTER EXTENSION SET
K Number: K912848
·
Decision Nov 29, 1991
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
10
Review Days
154
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Basic Information
- Device Name
- I.V. FILTER EXTENSION SET
- K Number
- K912848
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Filtertek, Inc.
- Date Received
- June 28, 1991
- Decision Date
- November 29, 1991
- Product Code
- FPB
- 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 |
|---|---|---|---|
| FPB | Filter, Infusion Line | FDA class 2 | General Hospital |
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Other Clearances by Filtertek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981548 | NFC NEEDLEFREE CONNECTOR MODEL 69900 | Jun 18, 1998 | Substantially Equivalent |
| K981547 | NFC NEEDLEFREE Y-SITE, MODEL 69970 | Jun 18, 1998 | Substantially Equivalent |
| K914792 | PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET | Jan 15, 1992 | Substantially Equivalent |
| K912394 | TRANSDUCER PROTECTOR | Aug 30, 1991 | Substantially Equivalent |
| K911451 | I.V. EXTENDER SET | Jun 6, 1991 | Substantially Equivalent |
| K904912 | TRANSDUCER PROTECTOR | Jan 4, 1991 | Substantially Equivalent |
| K901409 | TRANSDUCER PROTECTOR | Jul 27, 1990 | Substantially Equivalent |
| K901996 | FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR | Jun 1, 1990 | Substantially Equivalent |
| K895281 | TRANSDUCER PROTECTOR | Nov 8, 1989 | Substantially Equivalent |