FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VENT-O2-CATH
K Number: K760371
·
Decision Aug 13, 1976
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
21
Review Days
8
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
- VENT-O2-CATH
- K Number
- K760371
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Dryden Corp.
- Date Received
- August 5, 1976
- Decision Date
- August 13, 1976
- 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 Dryden Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K880923 | PATIENT VENTILATOR ISOLATOR | Sep 6, 1988 | Substantially Equivalent |
| K880769 | BREATHING CIRCUIT W/HEATED WIRE | Aug 24, 1988 | Substantially Equivalent |
| K882285 | NONREBREATHING CIRCUIT | Aug 16, 1988 | Substantially Equivalent |
| K873928 | UNIVERSAL TOURNIQUET | Oct 23, 1987 | Substantially Equivalent |
| K873927 | REUSEABLE BREATHING TUBES | Oct 20, 1987 | Substantially Equivalent |
| K870859 | BAG-TAIL BLEED VALVE | Aug 3, 1987 | Substantially Equivalent |
| K871386 | BREATHING CIRCUIT | May 29, 1987 | Substantially Equivalent |
| K870858 | BADGWELL SAMPLING CATHETER | May 14, 1987 | Substantially Equivalent |
| K861540 | DISPOSABLE BERMAN AND GUEDEL AIRWAYS | May 2, 1986 | Substantially Equivalent |
| K850644 | NASOPHARYNGEAL AIRWAY-ROBERTAZZI | Mar 21, 1985 | Substantially Equivalent |