FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRASET CATHETER
K Number: K911294
·
Decision Jun 10, 1991
Classifications
1
FEI Numbers
167
Registration Numbers
167
Same Product Code
93
Applicant Total
11
Review Days
77
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
- ULTRASET CATHETER
- K Number
- K911294
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Dhd Diemolding Healthcare Div.
- Date Received
- March 25, 1991
- Decision Date
- June 10, 1991
- Product Code
- BZA
- 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 |
|---|---|---|---|
| BZA | Connector, Airway (Extension) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZA), ordered by most recent decision date.
TRACH-ASSIST
FDA 510(k)
FDA Class 1
·Anesthesiology
SURELOC CIRCUIT CONNECTOR
FDA 510(k)
FDA Class 1
·Anesthesiology
DISPOSABLE FLEX TUBE
FDA 510(k)
FDA Class 1
·Anesthesiology
UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS
FDA 510(k)
FDA Class 1
·Anesthesiology
NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR
FDA 510(k)
FDA Class 1
·Anesthesiology
DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Dhd Diemolding Healthcare Div.
| K Number | Device Name | ||
|---|---|---|---|
| K973532 | STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR | Mar 19, 1998 | Substantially Equivalent |
| K970596 | DHD EMERALD PRODUCT | May 16, 1997 | Substantially Equivalent |
| K961973 | DHD ACE WITH MASK KIT | Aug 15, 1996 | Substantially Equivalent |
| K953206 | DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION) | Aug 28, 1995 | Substantially Equivalent |
| K945118 | EXPIRATORY BREATHING EXERCISER | Jan 13, 1995 | Substantially Equivalent |
| K944900 | THERAPEP | Jan 6, 1995 | Substantially Equivalent |
| K926301 | ACE AEROSOL ENHANCER, HAND HELD ORAL INHALATION CO | Jul 21, 1993 | Substantially Equivalent |
| K922537 | DURALIFE | Dec 4, 1992 | Substantially Equivalent |
| K913726 | DURALIFE(TM) | Feb 7, 1992 | Substantially Equivalent |
| K913326 | DHD METERED DOSE INHALER (MDI) SPACER | Jan 7, 1992 | Substantially Equivalent |