510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K030734Substantially Equivalent

Pathway Access Sheath Catheter

Vertelink Corporation, Mission Viejo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K030734 is the FDA 510(k) clearance record for PATHWAY ACCESS SHEATH CATHETER, a class II device, cleared for Vertelink Corporation on under FDA product code DYB (Introducer, Catheter). FDA records list 3 510(k) clearances for Vertelink Corporation, from to . As of , FDA records show no recalls naming K030734.

Clearance record

Decision date
Received
(184 days to decision)
Product code
DYB Introducer, Catheter
Regulation
21 CFR 870.1340
Device class
Class II
Review panel
Cardiovascular
Applicant
Vertelink Corporation 27001 La Paz, Suite 312, Mission Viejo CA
510(k) summary
Statement
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