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

CONNELL-STEPHENS ENDO ANESS TUBE

K Number: K895132 · Decision Oct 13, 1989
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
4
Review Days
57

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
CONNELL-STEPHENS ENDO ANESS TUBE
K Number
K895132
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5730
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
The Traumafuse Co.
Date Received
August 17, 1989
Decision Date
October 13, 1989
Product Code
BTR
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
BTR Tube, Tracheal (W/Wo Connector)

Similar 510(k) Clearances

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

View all

Other Clearances by The Traumafuse Co.

K Number Device Name
K895162 TRAUMAFUSE TRACH SHIELD
K894721 TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE
K890077 TRAUMAFUSE RAPID INFUSION DEVICE