FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RMI CARDIOPLEGIA DELIVERY SETS
K Number: K892368
·
Decision Dec 7, 1989
Classifications
1
FEI Numbers
149
Registration Numbers
150
Same Product Code
137
Applicant Total
35
Review Days
245
Basic Information
- Device Name
- RMI CARDIOPLEGIA DELIVERY SETS
- K Number
- K892368
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4290
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- RESEARCH MEDICAL, INC.
- Date Received
- April 6, 1989
- Decision Date
- December 7, 1989
- Product Code
- DTL
- 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 |
|---|---|---|---|
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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| K922083 | RMI SURGICCAL SITE VISUALIZATION WAND | Jan 29, 1993 | Substantially Equivalent |
| K920936 | RMI EXTERNAL CORONARY ARTERY OCCLUDER | Dec 18, 1992 | Substantially Equivalent |
| K915869 | RMI NORMOCLUDER CORONARY ARTERY OCCLUDER | Dec 8, 1992 | Substantially Equivalent |
| K920676 | RMI SOFCLAMP | Apr 15, 1992 | Substantially Equivalent |
| K910221 | RMI VASCULAR TOURNIQUET KIT | May 16, 1991 | Substantially Equivalent |