510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K140944Substantially Equivalent

1.8 Mm Phoenix Atherectomy Catheter, 2.2 Mm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip

Atheromed, Inc., Menlo Park CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140944 is the FDA 510(k) clearance record for 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP, a class II device, cleared for Atheromed, Inc. on under FDA product code MCW (Catheter, Peripheral, Atherectomy). FDA records list 2 510(k) clearances for Atheromed, Inc., from to . As of , FDA records show no recalls naming K140944.

Clearance record

Decision date
Received
(130 days to decision)
Product code
MCW Catheter, Peripheral, Atherectomy
Regulation
21 CFR 870.4875
Device class
Class II
Review panel
Cardiovascular
Applicant
Atheromed, Inc. 1455 Adams Dr., Suite 1120, Menlo Park CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MCW

Trailing 12 months
1 clearance under product code MCW 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 MCW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260