Medical Device Manufacturer · US , Sylmar , CA

Pacesetter, Inc. - FDA 510(k) Cleared Devices

8 submissions · 2 cleared · Since 1995

Recent clearances: LOCATOR MODEL 4036, SIEMENS SERVO ULTRA NEBULIZER 345, AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)

8

Total

2

Cleared

0

Denied

Pacesetter, Inc. has 2 FDA 510(k) cleared medical devices. Based in Sylmar, US.

Historical record: 2 cleared submissions from 1995 to 1998. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Pacesetter, Inc. Filter by specialty or product code using the sidebar.

Pacesetter, Inc. is one of 9140 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Pacesetter, Inc.

8 devices

1-8 of 8

Cleared Feb 23, 1998

LOCATOR MODEL 4036

Cardiovascular · 209d

Cleared Dec 23, 1996

SIEMENS SERVO ULTRA NEBULIZER 345

Anesthesiology · 297d

Cleared Feb 01, 1996

AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)

Cardiovascular · 122d

Cleared Dec 26, 1995

DF-1 TERMINAL CAP

Cardiovascular · 85d

Cleared Aug 31, 1995

PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING

Cardiovascular · 127d

Cleared Aug 31, 1995

PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING

Cardiovascular · 113d

Cleared Jun 29, 1995

TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD

Cardiovascular · 112d

Cleared Apr 06, 1995

IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069

Cardiovascular · 83d