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

WILSON BIOMEDICAL CORONARY GUIDING CATHETER

K Number: K881793 · Decision Oct 19, 1988
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
2
Review Days
176

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
WILSON BIOMEDICAL CORONARY GUIDING CATHETER
K Number
K881793
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1250
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Wilson Biomedical, Inc.
Date Received
April 26, 1988
Decision Date
October 19, 1988
Product Code
DQY
Advisory Committee
Cardiovascular
Review Advisory Committee
CV
Third Party
N

Classifications

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

Product Code Device Name
DQY Catheter, Percutaneous

Similar 510(k) Clearances

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

View all

Other Clearances by Wilson Biomedical, Inc.

K Number Device Name
K892671 WILSON BIOMEDICAL ANGIOGRAPHIC CATHETER