FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROBE & CATHETER
K Number: K771663
·
Decision Sep 20, 1977
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
36
Applicant Total
12
Review Days
21
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Basic Information
- Device Name
- PROBE & CATHETER
- K Number
- K771663
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1915
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Edwards Laboratories
- Date Received
- August 30, 1977
- Decision Date
- September 20, 1977
- 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 Edwards Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K801552 | MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR | Jul 28, 1980 | Substantially Equivalent |
| K800655 | MODEL 100 SPECTRAVIEW | Apr 16, 1980 | Substantially Equivalent |
| K792441 | CARPENTIER-EDWARDS FLEX. ANNULOPLASTY | Mar 17, 1980 | Substantially Equivalent - Subject to Tracking & PMS |
| K792034 | INTEGRAL DISPOSABLE HOLDER CARPENTIER | Dec 7, 1979 | Substantially Equivalent |
| K790047 | CARDIAC OUTPUT COMPUTER, MDEL 9520A | Feb 26, 1979 | Substantially Equivalent |
| K790022 | DISPOSABLE HOLDER FOR BIOPROSTHESIS | Jan 15, 1979 | Substantially Equivalent |
| K781535 | AC ADAPTER:MODELS 9525,9526,9527 | Sep 15, 1978 | Substantially Equivalent |
| K771046 | VENA CAVA UMBRELLA FILTER, MODEL 7321 | Jun 22, 1977 | Substantially Equivalent |
| K760151 | APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) | Aug 26, 1976 | Substantially Equivalent |
| K760152 | FILTER (7220&7221 MOBIN-UDDIN VENA CAVA) | Jul 19, 1976 | Substantially Equivalent |