FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PVC LINES FOR MONITORING
K Number: K780985
·
Decision Jul 27, 1978
Classifications
1
FEI Numbers
206
Registration Numbers
206
Same Product Code
26
Applicant Total
39
Review Days
43
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
- PVC LINES FOR MONITORING
- K Number
- K780985
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Norton Performance Plastics Corp.
- Date Received
- June 14, 1978
- Decision Date
- July 27, 1978
- Product Code
- GAZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| GAZ | Tubing, Noninvasive | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAZ), ordered by most recent decision date.
SUCTION/IRRIGATOR TUBING KIT
FDA 510(k)
FDA Class 2
·General Hospital
TUBING, NONINVASIVE
FDA 510(k)
FDA Class 2
·General Hospital
SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES
FDA 510(k)
FDA Class 2
·General Hospital
NORTEC CONNECTING TUBE SET
FDA 510(k)
FDA Class 2
·General Hospital
MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE
FDA 510(k)
FDA Class 2
·General Hospital
MAXI-FLOW SUCTION SET W/Y CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Norton Performance Plastics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K853791 | NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 | Dec 9, 1985 | Substantially Equivalent |
| K852914 | ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION | Sep 25, 1985 | Substantially Equivalent |
| K851299 | CORRECT FLO | May 7, 1985 | Substantially Equivalent |
| K842858 | FLUID ADMINISTRATION LINE W/SPIKE 14-923 | Sep 11, 1984 | Substantially Equivalent |
| K841828 | CENTRAL VENOUS CATHETER W/BIG-GARD | Jul 13, 1984 | Substantially Equivalent |
| K840240 | MICROFUSE INTRAVENOUS CATHETER SET | Apr 17, 1984 | Substantially Equivalent |
| K831587 | TEMP. REPAIR KIT-DUAL LUMEN CATHETER | Oct 19, 1983 | Substantially Equivalent |
| K831698 | DISPOSABLE PRESSURE TRANSDUCER#14004195 | Aug 11, 1983 | Substantially Equivalent |
| K830788 | CENTRAL VEIN CATHERIZATION KIT-14-690- | Apr 30, 1983 | Substantially Equivalent |
| K830813 | FRENCH PERCUTANEOUS SHEATH INTRODUCER | Apr 28, 1983 | Substantially Equivalent |