FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

INFECTION CONTROL VALVE

K Number: K841480 · Decision Apr 25, 1984
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
15
Review Days
16

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
INFECTION CONTROL VALVE
K Number
K841480
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.6810
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Superior Plastic Products Corp.
Date Received
April 9, 1984
Decision Date
April 25, 1984
Product Code
BSY
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
BSY Catheters, Suction, Tracheobronchial

Similar 510(k) Clearances

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

View all

Other Clearances by Superior Plastic Products Corp.

K Number Device Name
K851981 NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC.
K843975 9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE
K841945 ENTERAL FEEDING BOTTLE
K841630 ENTERAL NUTRITION PUMP
K840324 SILICONE SUMP DRAIN 20 & 40 FRENCH
K840323 SILICONE SUCTION & IRRIGATION DRAIN
K833687 DISPOS. ENTERIC FEEDING TUBES W/SAFE-T
K833947 SUPERIOR ENTERNAL FEEDING SYSTEM
K820460 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION
K812312 STERILE WATER 4OZ.
Search all 15 clearances from Superior Plastic Products Corp. →