FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RMI CARDIOPLEGIA DELIVERY KITS
K Number: K901231
·
Decision Jun 8, 1990
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
393
Applicant Total
35
Review Days
86
Basic Information
- Device Name
- RMI CARDIOPLEGIA DELIVERY KITS
- K Number
- K901231
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- RESEARCH MEDICAL, INC.
- Date Received
- March 14, 1990
- Decision Date
- June 8, 1990
- 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 MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K970739 | RMI HEMOCONCENTRATOR PREFERENCE PACK | Jul 8, 1997 | Substantially Equivalent |
| K964833 | RMI DUAL FLUID IRRIGATING SYRINGE | Feb 19, 1997 | Substantially Equivalent |
| K961927 | RMI HEMOCONCENTRACTOR TUBING SET | Aug 13, 1996 | Substantially Equivalent |
| K960098 | RMI INTERNAL MAMMARY ARTERY CANNULA | Mar 26, 1996 | Substantially Equivalent |
| K951344 | RMI HEMOCONCENTRATOR | Aug 15, 1995 | Substantially Equivalent |
| 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 |