Medical Device Manufacturer · US , Waltham , MA

Pace Medical - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 1987

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

Total

Cleared

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.

Pace Medical is one of 13119 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Pace Medical

19 devices

1-12 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

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

MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE

K912545 · DXY

Cardiovascular · 46d

Pace Medical - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Pace Medical

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