FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AFFINITY BLOOD PUMP SYSTEM
K Number: K964017
·
Decision Aug 5, 1997
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
51
Applicant Total
9
Review Days
302
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AFFINITY BLOOD PUMP SYSTEM
- K Number
- K964017
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avecor Cardiovascular, Inc.
- Date Received
- October 7, 1996
- Decision Date
- August 5, 1997
- Product Code
- DTQ
- 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 |
|---|---|---|---|
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DTQ), ordered by most recent decision date.
Essenz HLM, Essenz ILBM
FDA 510(k)
FDA Class 2
·Cardiovascular
Terumo Advanced Perfusion System 1
FDA 510(k)
FDA Class 2
·Cardiovascular
Essenz HLM
FDA 510(k)
FDA Class 2
·Cardiovascular
Stockert S5 System
FDA 510(k)
FDA Class 2
·Cardiovascular
Century Perfusion System
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Avecor Cardiovascular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973760 | AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE | Feb 18, 1998 | Substantially Equivalent |
| K971105 | MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM | Jul 11, 1997 | Substantially Equivalent |
| K952532 | AFFINITY ARTERIAL BLOOD FILTER | Oct 6, 1995 | 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 |