510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883000Substantially Equivalent

Acs Angioscope Guide Wire

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

K883000 is the FDA 510(k) clearance record for ACS ANGIOSCOPE GUIDE WIRE, a class II device, cleared for Advanced Cardiovascular Systems, Inc. on under FDA product code LYK (Angioscope). FDA records list 103 510(k) clearances for Advanced Cardiovascular Systems, Inc., from to . As of , FDA records show no recalls naming K883000.

Clearance record

Decision date
Received
(72 days to decision)
Product code
LYK Angioscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Advanced Cardiovascular Systems, Inc. 1395 Charleston Rd., Mountain View CA
Third party review
No

Clearances, product code LYK

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