FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MGN SUCTION CATHETER
K Number: K811542
·
Decision Jun 18, 1981
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
4
Review Days
17
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MGN SUCTION CATHETER
- K Number
- K811542
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Mgn Medical Manufacturing, Inc.
- Date Received
- June 1, 1981
- Decision Date
- June 18, 1981
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BSY), ordered by most recent decision date.
MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
AMBU HAND POWER SUCTION PUMP
FDA 510(k)
FDA Class 1
·Anesthesiology
DUAL PURPOSE CLOSED CATHETER
FDA 510(k)
FDA Class 1
·Anesthesiology
SUCTION CATHETER
FDA 510(k)
FDA Class 1
·Anesthesiology
HI-CARE CLOSED SUCTION SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
AMSINO SUCTION CATHETER
FDA 510(k)
FDA Class 1
·Anesthesiology