510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K875158Substantially Equivalent

Acs Funnel Introducer

Advanced Cardiovascular Systems, Inc., Temecula CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875158 is the FDA 510(k) clearance record for ACS FUNNEL INTRODUCER, a class II device, cleared for Advanced Cardiovascular Systems, Inc. on under FDA product code DYB (Introducer, Catheter). FDA records list 103 510(k) clearances for Advanced Cardiovascular Systems, Inc., from to . As of , FDA records show no recalls naming K875158.

Clearance record

Decision date
Received
(168 days to decision)
Product code
DYB Introducer, Catheter
Regulation
21 CFR 870.1340
Device class
Class II
Review panel
Cardiovascular
Applicant
Advanced Cardiovascular Systems, Inc. 26531 Ynez Rd., Temecula CA
Third party review
No

Clearances, product code DYB

Trailing 12 months
19 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 20261