Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

96 results for "Pacesetter Systems"
1–24 of 96
Search insights Median review: 60d Cleared: 100% Top manufacturer: Pacesetter Systems Lead specialty: Cardiovascular
Cleared Aug 28, 1991
ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE
K910924 · DTB
Pacesetter Systems
Cardiovascular · 176d
Cleared Jul 17, 1990
ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
K902147 · DTB
Pacesetter Systems
Cardiovascular · 63d
Cleared Jun 25, 1990
SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS
K900512 · DTD
Pacesetter Systems
Cardiovascular · 143d
Cleared Apr 20, 1990
FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T
K900550 · DTB
Pacesetter Systems
Cardiovascular · 73d
Cleared Dec 20, 1989
ENDOCARDIAL SCREW-IN LEAD MODEL 1020T
K895447 · DTB
Pacesetter Systems
Cardiovascular · 103d
Cleared Jun 05, 1989
CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE
K891905 · DTB
Pacesetter Systems
Cardiovascular · 70d
Cleared Mar 28, 1989
VS-1 MODEL NUMBER 251K PULSE GENERATOR
K885267 · DXY
Pacesetter Systems
Cardiovascular · 96d
Cleared Mar 22, 1989
SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS
K890547 · DTB
Pacesetter Systems
Cardiovascular · 47d
Cleared Feb 10, 1989
AFP MODEL 262T PULSE GENERATOR
K884733 · DXY
Pacesetter Systems
Cardiovascular · 92d
Cleared Sep 14, 1988
PROLOG MP 658M PULSE GENERATOR
K883087 · DXY
Pacesetter Systems
Cardiovascular · 55d
Cleared Feb 02, 1988
ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T
K874205 · DTB
Pacesetter Systems
Cardiovascular · 110d
Cleared Nov 04, 1987
PROLOG MP PULSE GENERATORS 658K AND 658T
K872779 · DXY
Pacesetter Systems
Cardiovascular · 113d
Cleared Oct 22, 1987
MODIFIED MODELS 1025M & 1026T PACING LEAD
K873931 · DTB
Pacesetter Systems
Cardiovascular · 38d
Cleared Jun 05, 1987
UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M
K871208 · DYB
Pacesetter Systems
Cardiovascular · 72d
Cleared Mar 20, 1987
ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035
K870824 · DTB
Pacesetter Systems
Cardiovascular · 66d
Cleared Feb 03, 1987
DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS
K862226 · DXY
Pacesetter Systems
Cardiovascular · 237d
Cleared Jun 26, 1986
PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY
K861422 · DXY
Pacesetter Systems
Cardiovascular · 71d
Cleared Jun 09, 1986
SOF SET, MODELS 111 AND 112
K861436 · FRN
Pacesetter Systems
General Hospital · 53d
Cleared Jun 06, 1986
ENDOCARDIAL CARBON-TIP LEAD
K861481 · DTB
Pacesetter Systems
Cardiovascular · 45d
Cleared May 27, 1986
SOF SET, MODELS 113 AND 114
K860857 · FRN
Pacesetter Systems
General Hospital · 81d
Cleared May 19, 1986
LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS
K861464 · DTB
Pacesetter Systems
Cardiovascular · 28d
Cleared May 13, 1986
LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO
K861440 · DTB
Pacesetter Systems
Cardiovascular · 26d
Cleared May 02, 1986
PROGRAMALITH III PULSE GENERATOR
K861140 · DXY
Pacesetter Systems
Cardiovascular · 37d
Cleared Apr 23, 1986
DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37
K860546 · KRG
Pacesetter Systems
Cardiovascular · 69d