FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RESU-GARD CATHETER SUCTION
K Number: K902093
·
Decision Oct 23, 1990
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
2
Review Days
167
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
- RESU-GARD CATHETER SUCTION
- K Number
- K902093
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Amg Medical Equipments, Inc.
- Date Received
- May 9, 1990
- Decision Date
- October 23, 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 |
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
Other Clearances by Amg Medical Equipments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884917 | RESUSCITATOR'S GUARD SUCTION CONTROL SYSTEM | Mar 9, 1989 | Substantially Equivalent |