510(k) K951721

APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE by Applied Medical Resources — Product Code LYK

K951721 is an FDA 510(k) premarket notification submitted by Applied Medical Resources for the device "APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE". The FDA issued a decision of Substantially Equivalent on July 11, 1995. The device falls under product code LYK (Angioscope), a Class II device regulated under 21 CFR 876.1500. Applied Medical Resources has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1995
Date Received
April 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Angioscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
CV
Submission Type