FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE
K Number: K990103
·
Decision Nov 5, 1999
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
253
Applicant Total
15
Review Days
297
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Basic Information
- Device Name
- MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE
- K Number
- K990103
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4350
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sorin Biomedical, Inc.
- Date Received
- January 12, 1999
- Decision Date
- November 5, 1999
- Product Code
- DTZ
- 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 |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Sorin Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K961869 | DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 | Aug 12, 1996 | 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 |