510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945543Substantially Equivalent

Gamgro Engstrom Y Filter with Edith Flex (1500 F), Edit 500, 1000, 2600 and Y Filter Packaged Alone

Intersect Medical Products, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945543 is the FDA 510(k) clearance record for GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE, a class II device, cleared for Intersect Medical Products, Inc. on under FDA product code CAH (Filter, Bacterial, Breathing-Circuit). FDA records list 5 510(k) clearances for Intersect Medical Products, Inc., from to . As of , FDA records show no recalls naming K945543.

Clearance record

Decision date
Received
(15 days to decision)
Product code
CAH Filter, Bacterial, Breathing-Circuit
Regulation
21 CFR 868.5260
Device class
Class II
Review panel
Anesthesiology
Applicant
Intersect Medical Products, Inc. 4503 Moorland Ave., Minneapolis MN
510(k) summary
Statement
Third party review
No

Clearances, product code CAH

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