FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
SUCTION CATHETER KIT
K Number: K861949
·
Decision Oct 22, 1986
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
9
Review Days
155
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Basic Information
- Device Name
- SUCTION CATHETER KIT
- K Number
- K861949
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medi-Craft , Ltd.
- Date Received
- May 20, 1986
- Decision Date
- October 22, 1986
- 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 Medi-Craft , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K800508 | STOMACH TUBES | Apr 8, 1980 | Substantially Equivalent |
| K800510 | RECTAL & HARRIS FLUSH TUBES | Apr 8, 1980 | Substantially Equivalent |
| K800505 | URETHRAL CATHETER | Apr 8, 1980 | Substantially Equivalent |
| K800507 | FEEDING TUBES | Apr 8, 1980 | Substantially Equivalent |
| K800509 | CONNECTING TUBES | Mar 25, 1980 | Substantially Equivalent |
| K800506 | OXYGEN CATHETER | Mar 25, 1980 | Substantially Equivalent |
| K800503 | SUCTION CATHETER | Mar 18, 1980 | Substantially Equivalent |
| K800504 | OXYGEN CONNECTING TUBES | Mar 18, 1980 | Substantially Equivalent |