FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AFFINITY ARTERIAL BLOOD FILTER
K Number: K952532
·
Decision Oct 6, 1995
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
95
Applicant Total
9
Review Days
127
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Basic Information
- Device Name
- AFFINITY ARTERIAL BLOOD FILTER
- K Number
- K952532
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4260
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avecor Cardiovascular, Inc.
- Date Received
- June 1, 1995
- Decision Date
- October 6, 1995
- 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 Avecor Cardiovascular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973760 | AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE | Feb 18, 1998 | Substantially Equivalent |
| K964017 | AFFINITY BLOOD PUMP SYSTEM | Aug 5, 1997 | Substantially Equivalent |
| K971105 | MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM | Jul 11, 1997 | Substantially Equivalent |
| K940126 | AVECOR PRE-BYPASS FILTER | Jun 28, 1994 | Substantially Equivalent |
| K936003 | AFFINITY CVR | Jun 20, 1994 | Substantially Equivalent |
| K935717 | AFFINITY VENOUS RESERVIOR BAG | May 10, 1994 | Substantially Equivalent |
| K932252 | AFFINITY HOLLOW FIBER OXYGENATOR | Nov 19, 1993 | Substantially Equivalent |
| K924529 | SIGNATURE(TM) CUSTOM TUBING PACK | Jun 23, 1993 | Unknown |