510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K970392Substantially Equivalent

Cordis Avanti+catheter Sheath Introducer System

Cordis US Corp., Miami Lakes FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970392 is the FDA 510(k) clearance record for CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM, a class II device, cleared for Cordis Corp. on under FDA product code DRE (Dilator, Vessel, For Percutaneous Catheterization). FDA records list 332 510(k) clearances for Cordis US Corp., from to . As of , FDA records show 2 recalls naming K970392.

Clearance record

Decision date
Received
(80 days to decision)
Product code
DRE Dilator, Vessel, For Percutaneous Catheterization
Regulation
21 CFR 870.1310
Device class
Class II
Review panel
Cardiovascular
Applicant
Cordis Corp. 14201 NW 60th Ave., Miami Lakes FL
510(k) summary
Summary
Third party review
No

Clearances, product code DRE

Trailing 12 months
2 clearances under product code DRE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260