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

Pace Medical has 19 FDA 510(k) cleared cardiovascular devices. Based in Waltham, US.

Historical record: 19 cleared submissions from 1987 to 2001.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Pace Medical

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
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