FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOTRACHEAL TUBES, LONG & SHORT TERM
K Number: K791046
·
Decision Jun 13, 1979
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
69
Review Days
8
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Basic Information
- Device Name
- ENDOTRACHEAL TUBES, LONG & SHORT TERM
- K Number
- K791046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Extracorporeal Medical Specialities, Inc.
- Date Received
- June 5, 1979
- Decision Date
- June 13, 1979
- Product Code
- BTR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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Other Clearances by Extracorporeal Medical Specialities, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K843955 | EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR | Nov 29, 1984 | Substantially Equivalent |
| K840532 | HEMOPERFUSION SYSTEM TP-400 | May 30, 1984 | Substantially Equivalent |
| K840262 | HANCOCK PERICARDIAL PATCH | May 30, 1984 | Substantially Equivalent |
| K840146 | EXP* 700 PARALLEL PLATE DIALYZER | Feb 4, 1984 | Substantially Equivalent |
| K840057 | EXP* 500 PARALLEL PLATE DIALYZER | Feb 4, 1984 | Substantially Equivalent |
| K831423 | THERAPEUTIC EXCHANGE SYSTEM | Jan 3, 1984 | Substantially Equivalent |
| K832547 | ULTRAFILTRATION CONTROLLER | Jan 3, 1984 | Substantially Equivalent |
| K833477 | INTERSEPT 40 MICRON FILTER | Dec 27, 1983 | Substantially Equivalent |
| K833476 | INTERSEPT 40 MICRON FILTER W/TUBING | Dec 27, 1983 | Substantially Equivalent |
| K831424 | THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 | Oct 14, 1983 | Substantially Equivalent |