FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOPLEGIC SETS
K Number: K802545
·
Decision Jan 16, 1981
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
90
Applicant Total
30
Review Days
93
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Basic Information
- Device Name
- CARDIOPLEGIC SETS
- K Number
- K802545
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Texas Medical Products, Inc.
- Date Received
- October 15, 1980
- Decision Date
- January 16, 1981
- Product Code
- DTR
- 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 |
|---|---|---|---|
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Texas Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K893417 | SURGIFRESH SUB-MICRON MASK NO. 901008-000 | Jun 22, 1989 | Substantially Equivalent |
| K870932 | SURGIFRESH SURGICAL SMOKE REMOVAL | Mar 31, 1987 | Substantially Equivalent |
| K851575 | DR. BRUNO LNAGE MINI PHOTOMETER | Oct 18, 1985 | Substantially Equivalent |
| K830634 | CARDIOTOMY FILTER | Jun 30, 1983 | Substantially Equivalent |
| K813587 | DISPOSABLE THORACIC CATHETER | Jan 12, 1982 | Substantially Equivalent |
| K810532 | DISPOSABLE STOPCOCK | Apr 23, 1981 | Substantially Equivalent |
| K810515 | DISPOSABLE 2-STAGE CANNULA | Apr 23, 1981 | Substantially Equivalent |
| K810395 | PRE-BYPASS FILTER | Mar 5, 1981 | Substantially Equivalent |
| K802543 | RIDGID VENA CAVA CANNULAE | Jan 16, 1981 | Substantially Equivalent |
| K802544 | DISPOSABLE QUICK RELEASE PERFUSION ADAP | Jan 16, 1981 | Substantially Equivalent |