510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K994334Substantially Equivalent

Ultra-Flex Hemostasis Introducer. Model 406Xxx

Daig Corp., Minnetonka MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K994334 is the FDA 510(k) clearance record for ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX, a class II device, cleared for Daig Corp. on under FDA product code DYB (Introducer, Catheter). FDA records list 35 510(k) clearances for Daig Corp., from to . As of , FDA records show no recalls naming K994334.

Clearance record

Decision date
Received
(144 days to decision)
Product code
DYB Introducer, Catheter
Regulation
21 CFR 870.1340
Device class
Class II
Review panel
Cardiovascular
Applicant
Daig Corp. 14901 Deveau Pl., Minnetonka MN
510(k) summary
Summary
Third party review
No

Clearances, product code DYB

Trailing 12 months
18 clearances under product code DYB in the twelve months to October 2026, April 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code DYB, trailing twelve months
MonthClearances
November 20250
December 20252
January 20261
February 20262
March 20261
April 20267
May 20260
June 20263
July 20262
August 20260
September 20260
October 20260