Pace Medical - FDA 510(k) Cleared Devices
Recent clearances: ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825, DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260, PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
19
Total
19
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pace Medical Cardiovascular ✕
19 devices
Cleared
Sep 12, 2001
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
Cardiovascular
79d
Cleared
Sep 04, 2001
DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
Cardiovascular
39d
Cleared
Oct 18, 2000
PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
Cardiovascular
90d
Cleared
Oct 10, 2000
MODEL 4815 ADAPTER
Cardiovascular
57d
Cleared
Oct 10, 2000
MODEL 4810 ANALYZER OUTPUT ADAPTER
Cardiovascular
57d
Cleared
Jun 27, 2000
TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY...
Cardiovascular
77d
Cleared
Sep 27, 1994
MODEL 4800 ACCUPACE PACING SYSTEM ANALYER
Cardiovascular
714d
Cleared
Aug 31, 1993
LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES
Cardiovascular
148d
Cleared
Dec 23, 1992
MODEL 4280 SURGICAL EXTENSION CABLE
Cardiovascular
190d
Cleared
Nov 19, 1991
MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER
Cardiovascular
85d
Cleared
Aug 22, 1991
MODEL 4220
Cardiovascular
37d
Cleared
Jul 26, 1991
MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE
Cardiovascular
46d