FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇰 Denmark
SUCTION CATHETER STRAIGHT/COUDE
K Number: K896730
·
Decision Mar 30, 1990
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
7
Review Days
120
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Basic Information
- Device Name
- SUCTION CATHETER STRAIGHT/COUDE
- K Number
- K896730
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Unoplast A/S
- Date Received
- November 30, 1989
- Decision Date
- March 30, 1990
- Product Code
- BSY
- 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | FDA class 1 | Anesthesiology |
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Other Clearances by Unoplast A/S
| K Number | Device Name | ||
|---|---|---|---|
| K896734 | FEEDING TUBE | Dec 21, 1990 | Substantially Equivalent |
| K896729 | NELATON-, FEMALE - OR TIEMANN CATHETER | Nov 5, 1990 | Substantially Equivalent |
| K896732 | UNOMETER 500 | Nov 2, 1990 | Substantially Equivalent |
| K896731 | OXYGEN CATHETERS | Mar 30, 1990 | Substantially Equivalent |
| K896733 | VACCON | Feb 1, 1990 | Substantially Equivalent |
| K802248 | DISARP ORIGINAL | Sep 26, 1980 | Substantially Equivalent |