FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

STOPCOCK 2-WAY, 3-WAY & 4-WAY

K Number: K802258 · Decision Sep 26, 1980
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
19
Review Days
10

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
STOPCOCK 2-WAY, 3-WAY & 4-WAY
K Number
K802258
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5440
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Stanco Medical, Inc.
Date Received
September 16, 1980
Decision Date
September 26, 1980
Product Code
FMG
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
FMG Stopcock, I.V. Set

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (FMG), ordered by most recent decision date.

View all

Other Clearances by Stanco Medical, Inc.

K Number Device Name
K810642 ATRIAL-VENTRICULAR PACING ELECTRODE KIT
K810643 UNIVERSAL PACING ELECTRODE KIT
K802289 PERICARDIOCENTESIS KIT
K802288 SWAN GANZ CATHETER PLACEMENT KIT
K802287 RIGHT ATRIAL LINE KIT
K802259 TRANSVENOUS PACEMAKER ELECTRODE KIT
K802290 REGIONAL INTRAVENOUS ANESTHESIA KIT
K802326 PRESSURE MONITORING LINES
K802260 VASCULAR CATHETER WIREGUIDES
K802328 DISP. TOUGY-BORST TYPE ADAPTOR W/PORT
Search all 19 clearances from Stanco Medical, Inc. →