510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K912644Substantially Equivalent

Cordis Inflator Device

Cordis US Corp., Miami Lakes FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912644 is the FDA 510(k) clearance record for CORDIS INFLATOR DEVICE, a class II device, cleared for Cordis Corp. on under FDA product code MAV (Syringe, Balloon Inflation). FDA records list 332 510(k) clearances for Cordis US Corp., from to . As of , FDA records show no recalls naming K912644.

Clearance record

Decision date
Received
(91 days to decision)
Product code
MAV Syringe, Balloon Inflation
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Cordis Corp. 14201 NW 60th Ave., Miami Lakes FL
510(k) summary
Statement
Third party review
No

Clearances, product code MAV

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