FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER
K Number: K936091
·
Decision Dec 23, 1994
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
36
Applicant Total
13
Review Days
366
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Basic Information
- Device Name
- MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER
- K Number
- K936091
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4380
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Bio-Medicus, Inc.
- Date Received
- December 22, 1993
- Decision Date
- December 23, 1994
- Product Code
- DWA
- 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 |
|---|---|---|---|
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Medtronic Bio-Medicus, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973237 | CSS-CARDIOPLEGIA SAFETY SYSTEM | Apr 27, 1998 | Substantially Equivalent |
| K973011 | BPX80 BIO-PUMP (BPX80) | Feb 25, 1998 | Substantially Equivalent |
| K954501 | BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM | Jan 16, 1996 | Substantially Equivalent |
| K941922 | MEDSAT OXYGEN SATURATION SYSTEM | Feb 17, 1995 | Substantially Equivalent |
| K941921 | BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 | Jul 20, 1994 | Substantially Equivalent |
| K924208 | BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) | Jul 8, 1993 | Substantially Equivalent |
| K926357 | MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 | Jun 2, 1993 | Substantially Equivalent |
| K924206 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E | May 7, 1993 | Substantially Equivalent |
| K924205 | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 | May 6, 1993 | Substantially Equivalent |
| K924642 | MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER | Mar 26, 1993 | Substantially Equivalent |