FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BENTLEY THEROMODILUTION CATHETER #BTD-7F
K Number: K802133
·
Decision Sep 26, 1980
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
36
Applicant Total
55
Review Days
22
Basic Information
- Device Name
- BENTLEY THEROMODILUTION CATHETER #BTD-7F
- K Number
- K802133
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1915
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- BENTLEY LABORATORIES, INC.
- Date Received
- September 4, 1980
- Decision Date
- September 26, 1980
- 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 BENTLEY LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
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| K913692 | VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) | Nov 15, 1991 | Substantially Equivalent |
| K903641 | QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q | Nov 9, 1990 | Substantially Equivalent |
| K894826 | UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF | Feb 28, 1990 | Substantially Equivalent |
| K874867 | CATR(TM)-H CARDIOTOMY HOLDER | Feb 2, 1988 | Substantially Equivalent |
| K874841 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER | Feb 2, 1988 | Substantially Equivalent |
| K874618 | BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER | Jan 19, 1988 | Substantially Equivalent |
| K823359 | OXYGEN CONSUMPTION MONITOR #OCM-0100 | Jan 5, 1983 | Substantially Equivalent |
| K823273 | BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. | Jan 5, 1983 | Substantially Equivalent |