Heart Technology Mfg., Inc. - FDA 510(k) Cleared Devices
Recent clearances: ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE, ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Heart Technology Mfg., Inc. Cardiovascular ✕
3 devices
Cleared
Apr 25, 1996
ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE
Cardiovascular
90d
Cleared
Jan 18, 1996
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE
Cardiovascular
106d
Cleared
Dec 22, 1995
ROTABLATOR ROTATIONAL ANGIOPLASTY
Cardiovascular
120d