510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K854273Substantially Equivalent

Silicone Oil 350 Cnetistoke

Pacific Medical Industries, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854273 is the FDA 510(k) clearance record for SILICONE OIL 350 CNETISTOKE, a class II device, cleared for Pacific Medical Industries on under FDA product code KRD (Device, Vascular, For Promoting Embolization). FDA records list one 510(k) clearance for Pacific Medical Industries. As of , FDA records show no recalls naming K854273.

Clearance record

Decision date
Received
(63 days to decision)
Product code
KRD Device, Vascular, For Promoting Embolization
Regulation
21 CFR 870.3300
Device class
Class II
Review panel
Cardiovascular
Applicant
Pacific Medical Industries 3134 Bunche Ave., San Diego CA
Third party review
No

Clearances, product code KRD

Trailing 12 months
8 clearances under product code KRD in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KRD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20261
May 20260
June 20262
July 20262
August 20260
September 20260
October 20261