FDA.reportPublic FDA data

510(k) K921318

Device
ADAPTING SLEEVE KIT MODEL 4023
Applicant
SIEMENS-PACESETTER, INC.
510(k) number
K921318
Product code
DTD  
Decision
Substantially Equivalent (SESE)
Decision date
1992-08-03
Date received
1992-03-19
Regulation
870.3620
Classification name
Pacemaker Lead Adaptor
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GLENN THOMPSON
Address
15900 Valley View Ct. P.O. Box 9221 Sylmar CA US 91392 91392

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DTD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K143463IS4/DF4 Port PlugOscor, Inc.2015-03-19
K1320086981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAPMedtronic, Inc.2013-07-30
K041574CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020Guidant Corporation2004-07-12
K031164PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLVOscor, Inc.2003-06-19
K024156PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAROscor, Inc.2003-01-14
K010787PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONSOscor, Inc.2001-05-22
K003454A1-CS-SB Y-ADAPTER, MODEL 124 871Biotronik, Inc.2001-01-18
K000210MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KITMedtronic Vascular2000-02-23
K982220MODEL 2872 BIPOLAR LEAD ADAPTOR KITMedtronic Vascular1998-10-15
K971930BK-N SEALING CAPBiotronik, Inc.1997-08-14
K970388A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVEBiotronik, Inc.1997-08-14
K970204BK-A; BK-B; BK-IS SEALING CAPBiotronik, Inc.1997-04-29
K950140IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069Pacesetter, Inc.1995-04-06
K934899BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MMTelectronics Pacing Systems, Inc.1994-05-12
K925168MISCELLANEOUS PACING LEADOscor Medical Corp.1994-05-03