510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K900978Substantially Equivalent

Manan Arterial Catheter Needle

Argon Medical Devices, Inc, Northbrook IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900978 is the FDA 510(k) clearance record for MANAN ARTERIAL CATHETER NEEDLE, a class II device, cleared for Manan Medical Products, Inc. on under FDA product code DQY (Catheter, Percutaneous). FDA records list 64 510(k) clearances for ARGON MEDICAL DEVICES INC., from to . As of , FDA records show no recalls naming K900978.

Clearance record

Decision date
Received
(174 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Manan Medical Products, Inc. 2200 Carlson Dr., Northbrook IL
Third party review
No

Clearances, product code DQY

Trailing 12 months
13 clearances under product code DQY in the twelve months to November 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQY, trailing twelve months
MonthClearances
December 20252
January 20260
February 20260
March 20261
April 20262
May 20260
June 20262
July 20263
August 20262
September 20261
October 20260
November 20260