Medical Device Manufacturer · US , Waltham , MA

Pace Medical - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 1987
19
Total
19
Cleared
0
Denied

FDA 510(k) Regulatory Record - Pace Medical Cardiovascular

19 devices
1-19 of 19
Cleared Sep 12, 2001
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
K011980 · DTE
Cardiovascular · 79d
Cleared Sep 04, 2001
DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
K012392 · DSA
Cardiovascular · 39d
Cleared Oct 18, 2000
PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
K002204 · DTE
Cardiovascular · 90d
Cleared Oct 10, 2000
MODEL 4815 ADAPTER
K002496 · DTN
Cardiovascular · 57d
Cleared Oct 10, 2000
MODEL 4810 ANALYZER OUTPUT ADAPTER
K002497 · DTC
Cardiovascular · 57d
Cleared Jun 27, 2000
TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY...
K001180 · DTE
Cardiovascular · 77d
Cleared Sep 27, 1994
MODEL 4800 ACCUPACE PACING SYSTEM ANALYER
K925143 · DTE
Cardiovascular · 714d
Cleared Aug 31, 1993
LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES
K931662 · DYB
Cardiovascular · 148d
Cleared Dec 23, 1992
MODEL 4280 SURGICAL EXTENSION CABLE
K922899 · DSA
Cardiovascular · 190d
Cleared Nov 19, 1991
MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER
K913805 · DTE
Cardiovascular · 85d
Cleared Aug 22, 1991
MODEL 4220
K913134 · DXY
Cardiovascular · 37d
Cleared Jul 26, 1991
MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE
K912545 · DXY
Cardiovascular · 46d
Cleared Jul 19, 1990
MODELS 4201, 4231 & 4235 EXTENSION CABLES
K902679 · DTE
Cardiovascular · 30d
Cleared Jan 24, 1990
MODEL EC4542G MINIATURE
K896352 · DTE
Cardiovascular · 79d
Cleared Aug 25, 1989
MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE
K890988 · LDF
Cardiovascular · 179d
Cleared Jan 19, 1988
PACING LEADS MODEL 3262VU/VB, 3362VU/VB, 3380/3390
K874743 · DTB
Cardiovascular · 62d
Cleared Jun 10, 1987
MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543
K871915 · DTE
Cardiovascular · 23d
Cleared Mar 03, 1987
MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER
K870323 · DTE
Cardiovascular · 34d
Cleared Jan 06, 1987
PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290
K864153 · DTB
Cardiovascular · 75d
Filters
All19 Cardiovascular 19