FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
K Number: K961869
·
Decision Aug 12, 1996
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
95
Applicant Total
15
Review Days
89
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Basic Information
- Device Name
- DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
- K Number
- K961869
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4260
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sorin Biomedical, Inc.
- Date Received
- May 15, 1996
- Decision Date
- August 12, 1996
- Product Code
- DTM
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | FDA class 2 | Cardiovascular |
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Other Clearances by Sorin Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990103 | MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE | Nov 5, 1999 | Substantially Equivalent |
| K963758 | CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE | Feb 20, 1998 | Substantially Equivalent |
| K963759 | DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS | Feb 20, 1998 | Substantially Equivalent |
| K964908 | VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER | Sep 3, 1997 | Substantially Equivalent |
| K964907 | VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT | Aug 21, 1997 | Substantially Equivalent |
| K952270 | DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN | Aug 21, 1995 | Substantially Equivalent |
| K945198 | DIDECO PEDIATRIC ARTERIAL FILTERS | Jun 27, 1995 | Substantially Equivalent |
| K945065 | DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 | May 19, 1995 | Substantially Equivalent |
| K941215 | VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR | May 10, 1995 | Substantially Equivalent |
| K942582 | SORIN BLOOD CARDIOPLEGIA CONSOLE | Jan 27, 1995 | Substantially Equivalent |