510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954604Substantially Equivalent

Rotablator Rotational Angioplasty System Rotablator System's Guide Wire Line; Hti Floppy

Heart Technology Mfg., Inc., Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954604 is the FDA 510(k) clearance record for ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY, a class II device, cleared for Heart Technology Mfg., Inc. on under FDA product code MCW (Catheter, Peripheral, Atherectomy). FDA records list 3 510(k) clearances for Heart Technology Mfg., Inc., from to . As of , FDA records show no recalls naming K954604.

Clearance record

Decision date
Received
(106 days to decision)
Product code
MCW Catheter, Peripheral, Atherectomy
Regulation
21 CFR 870.4875
Device class
Class II
Review panel
Cardiovascular
Applicant
Heart Technology Mfg., Inc. 17425 NE Union Hill Rd., Redmond WA
510(k) summary
Summary
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