FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERICARDIOCENTESIS KIT
K Number: K802289
·
Decision Nov 26, 1980
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
19
Review Days
68
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
- PERICARDIOCENTESIS KIT
- K Number
- K802289
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Stanco Medical, Inc.
- Date Received
- September 19, 1980
- Decision Date
- November 26, 1980
- Product Code
- DOR
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DOR | Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep. | FDA class 2 | Clinical Toxicology |
Other Clearances by Stanco Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K810642 | ATRIAL-VENTRICULAR PACING ELECTRODE KIT | Apr 8, 1981 | Substantially Equivalent |
| K810643 | UNIVERSAL PACING ELECTRODE KIT | Apr 8, 1981 | Substantially Equivalent |
| K802288 | SWAN GANZ CATHETER PLACEMENT KIT | Nov 20, 1980 | Substantially Equivalent |
| K802287 | RIGHT ATRIAL LINE KIT | Nov 20, 1980 | Substantially Equivalent |
| K802259 | TRANSVENOUS PACEMAKER ELECTRODE KIT | Oct 23, 1980 | Substantially Equivalent |
| K802290 | REGIONAL INTRAVENOUS ANESTHESIA KIT | Oct 17, 1980 | Substantially Equivalent |
| K802326 | PRESSURE MONITORING LINES | Oct 10, 1980 | Substantially Equivalent |
| K802260 | VASCULAR CATHETER WIREGUIDES | Oct 10, 1980 | Substantially Equivalent |
| K802328 | DISP. TOUGY-BORST TYPE ADAPTOR W/PORT | Oct 10, 1980 | Substantially Equivalent |
| K802327 | SHEATH DILATOR SET | Oct 10, 1980 | Substantially Equivalent |