FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RMI VASCULAR TOURNIQUET KIT
K Number: K910221
·
Decision May 16, 1991
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
203
Applicant Total
35
Review Days
119
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Basic Information
- Device Name
- RMI VASCULAR TOURNIQUET KIT
- K Number
- K910221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Research Medical, Inc.
- Date Received
- January 17, 1991
- Decision Date
- May 16, 1991
- Product Code
- DXC
- 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 |
|---|---|---|---|
| DXC | Clamp, Vascular | 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 |
| K901231 | RMI CARDIOPLEGIA DELIVERY KITS | Jun 8, 1990 | Substantially Equivalent |