510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813035Substantially Equivalent

Polystan Verticlude Blood Pump

Advocacy International, Ltd., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813035 is the FDA 510(k) clearance record for POLYSTAN VERTICLUDE BLOOD PUMP, a class II device, cleared for Advocacy International, Ltd. on under FDA product code DWB (Pump, Blood, Cardiopulmonary Bypass, Roller Type). FDA records list 13 510(k) clearances for Advocacy International, Ltd., from to . As of , FDA records show no recalls naming K813035.

Clearance record

Decision date
Received
(30 days to decision)
Product code
DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Regulation
21 CFR 870.4370
Device class
Class II
Review panel
Cardiovascular
Applicant
Advocacy International, Ltd. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DWB

Trailing 12 months

FDA records hold no clearances under product code DWB in the trailing twelve months.

FDA records show no clearances under product code DWB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DWB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260