FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTERFACE ARTERIAL BLOOD FILTER, MODEL 42
K Number: K862591
·
Decision Sep 4, 1986
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
94
Applicant Total
21
Review Days
59
Basic Information
- Device Name
- INTERFACE ARTERIAL BLOOD FILTER, MODEL 42
- K Number
- K862591
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4260
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- MEDICAL, INC.
- Date Received
- July 7, 1986
- Decision Date
- September 4, 1986
- 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 MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K926454 | ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON | Jun 22, 1993 | Unknown |
| K894839 | OS-1 OCCLUSION SYSTEM - 1 | Oct 24, 1989 | Substantially Equivalent |
| K872001 | MODEL TPC-1A OXYGEN ANALYZER | Jun 15, 1987 | Substantially Equivalent |
| K863806 | MODEL A-1 OXYGEN ANALYZER | Oct 15, 1986 | Substantially Equivalent |
| K862609 | INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 | Sep 4, 1986 | Substantially Equivalent |
| K861226 | INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 | Jun 2, 1986 | Substantially Equivalent |
| K851370 | INTERFACE TRANSFUSION BLOOD FILTER #35 | Jun 27, 1985 | Substantially Equivalent |
| K823261 | INTERFACE TRANSFUSION BLOOD FILTER #30 | Jan 7, 1983 | Substantially Equivalent |
| K823259 | INTERFACE CARDIOTOMY BLOOD FILTER #50 | Nov 24, 1982 | Substantially Equivalent |
| K823258 | INTERFACE ARTERIAL BLOOD FILTER #40 | Nov 24, 1982 | Substantially Equivalent |