510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914315Substantially Equivalent

Optical Catheter Introducer Sets, Modification

Medical Dynamics, Inc., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914315 is the FDA 510(k) clearance record for OPTICAL CATHETER INTRODUCER SETS, MODIFICATION, a class I device, cleared for Medical Dynamics, Inc. on under FDA product code KGX (Tape And Bandage, Adhesive). FDA records list 18 510(k) clearances for Medical Dynamics, Inc., from to . As of , FDA records show no recalls naming K914315.

Clearance record

Decision date
Received
(181 days to decision)
Product code
KGX Tape And Bandage, Adhesive
Regulation
21 CFR 880.5240
Device class
Class I
Review panel
General Hospital
Applicant
Medical Dynamics, Inc. 99 Inverness Dr. E., Englewood CO
510(k) summary
Statement
Third party review
No

Clearances, product code KGX

Trailing 12 months

FDA records hold no clearances under product code KGX in the trailing twelve months.

FDA records show no clearances under product code KGX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KGX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260