510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K871517Substantially Equivalent

Olympus Pf-25 Ultrathin Angioscope

Olympus Corp., Lake Success NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871517 is the FDA 510(k) clearance record for OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE, a class II device, cleared for Olympus Corp. on under FDA product code DQX (Wire, Guide, Catheter). FDA records list 149 510(k) clearances for Olympus Corp., from to . As of , FDA records show no recalls naming K871517.

Clearance record

Decision date
Received
(224 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Olympus Corp. 4 Nevada Dr., Lake Success NY
Third party review
No

Clearances, product code DQX

Trailing 12 months
13 clearances under product code DQX in the twelve months to October 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20263
February 20260
March 20263
April 20260
May 20261
June 20260
July 20262
August 20260
September 20262
October 20261