510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K891164Substantially Equivalent

Samuels - Micro -Scler Catheter

Polyval, Inc., San Gabriel CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891164 is the FDA 510(k) clearance record for SAMUELS - MICRO -SCLER CATHETER, a class II device, cleared for Polyval, Inc. on under FDA product code FPA (Set, Administration, Intravascular). FDA records list one 510(k) clearance for Polyval, Inc. As of , FDA records show no recalls naming K891164.

Clearance record

Decision date
Received
(109 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Polyval, Inc. 5108 Walnut Grove Ave., San Gabriel CA
Third party review
No

Clearances, product code FPA

Trailing 12 months
5 clearances under product code FPA 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 FPA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260