FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OCCLUSION & OCCLUSION-IRRIGATION
K Number: K844918
·
Decision Aug 5, 1985
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
11
Applicant Total
8
Review Days
229
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
- OCCLUSION & OCCLUSION-IRRIGATION
- K Number
- K844918
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1370
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Clincal Instruments Corp.
- Date Received
- December 19, 1984
- Decision Date
- August 5, 1985
- Product Code
- DQT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQT | Occluder, Catheter Tip | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQT), ordered by most recent decision date.
GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
FDA 510(k)
FDA Class 2
·Cardiovascular
THE OMNIGUIDE GUIDING CATHETER WITH BALLOON
FDA 510(k)
FDA Class 2
·Cardiovascular
CATHLAB SILICONE OCCLUSION BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
AVD INTIMAX OCCLUSION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Clincal Instruments Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K902327 | EMBOLECTOMY CATHETER | Feb 25, 1991 | Substantially Equivalent |
| K860742 | CAROTID BYPASS SHUNT | May 28, 1986 | Substantially Equivalent |
| K860743 | CAROTID BYPASS SHUNT WITH SAMPLING ARM | May 28, 1986 | Substantially Equivalent |
| K852704 | TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT | Nov 26, 1985 | Substantially Equivalent |
| K821220 | MULTILUMEN INTRAVENOUS INFUSION CATHETER | Jul 9, 1982 | Substantially Equivalent |
| K790034 | INTRODUCERS | Feb 1, 1979 | Substantially Equivalent |
| K771043 | SWAN GANZ | Dec 20, 1977 | Substantially Equivalent |