FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLOW DIRECTED THERMODILUTION CATH W/VEN
K Number: K843412
·
Decision Nov 20, 1984
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
36
Applicant Total
21
Review Days
81
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Basic Information
- Device Name
- FLOW DIRECTED THERMODILUTION CATH W/VEN
- K Number
- K843412
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1915
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Andover Medical, Inc.
- Date Received
- August 31, 1984
- Decision Date
- November 20, 1984
- Product Code
- KRB
- 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 |
|---|---|---|---|
| KRB | Probe, Thermodilution | FDA class 2 | Cardiovascular |
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Other Clearances by Andover Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905729 | CANMED 451 | Feb 7, 1991 | Substantially Equivalent |
| K903427 | NORTECH MODEL 86901000 ELECTRODE | Aug 17, 1990 | Substantially Equivalent |
| K885171 | MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE | Jan 12, 1989 | Substantially Equivalent |
| K860636 | FASTRACE III, ECG ELECTRODE | May 9, 1986 | Substantially Equivalent |
| K854433 | ECG MONITORING/DEFIBRILLATION ELECTRODE | May 8, 1986 | Substantially Equivalent |
| K860535 | UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) | Apr 1, 1986 | Substantially Equivalent |
| K860283 | AMI CARDIO-PAD | Mar 31, 1986 | Substantially Equivalent |
| K843410 | FLOW-DIRECTED PEDIATRIC THERMODIL- CATH | Nov 20, 1984 | Substantially Equivalent |
| K843411 | THERMAL DILUTION CATHETER | Oct 18, 1984 | Substantially Equivalent |
| K843409 | FLOW-DIRECTED THERMODILUTION CATH | Oct 18, 1984 | Substantially Equivalent |