FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTRACARDIA SUCKERS
K Number: K831759
·
Decision Aug 12, 1983
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
5
Review Days
72
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Basic Information
- Device Name
- INTRACARDIA SUCKERS
- K Number
- K831759
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Research Industries Corp.
- Date Received
- June 1, 1983
- Decision Date
- August 12, 1983
- Product Code
- DWF
- 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Research Industries Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K945931 | RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE | Mar 3, 1995 | Substantially Equivalent |
| K833433 | PHYSIO-PROBE-HIGH PERMEABILITY CATH. | Dec 29, 1983 | Substantially Equivalent |
| K832542 | I.V. ADMINISTRATION SET | Oct 31, 1983 | Substantially Equivalent |
| K831769 | VARIOUS CARDIOVASCULAR SURGICAL DEVICE | Aug 12, 1983 | Substantially Equivalent |