FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MULTILUMEN INTRAVENOUS INFUSION CATHETER
K Number: K821220
·
Decision Jul 9, 1982
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
2
Applicant Total
8
Review Days
73
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
- MULTILUMEN INTRAVENOUS INFUSION CATHETER
- K Number
- K821220
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Clincal Instruments Corp.
- Date Received
- April 27, 1982
- Decision Date
- July 9, 1982
- Product Code
- GBP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GBP | Catheter, Multiple Lumen | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBP), ordered by most recent decision date.
MENSINK-GOOSEN CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CATHETER, MULTIPLE LUMEN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| K844918 | OCCLUSION & OCCLUSION-IRRIGATION | Aug 5, 1985 | Substantially Equivalent |
| K790034 | INTRODUCERS | Feb 1, 1979 | Substantially Equivalent |
| K771043 | SWAN GANZ | Dec 20, 1977 | Substantially Equivalent |