510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Cardiac Pacemakers, Inc.

St Paul, MN, US

Cardiac Pacemakers, Inc. appears in FDA device records in St Paul, MN. FDA records list 76 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
76
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 76

FDA records hold 76 510(k) clearances for Cardiac Pacemakers, Inc. between 1977 and 2010. The busiest year on record is 1980, with 14. The most recent is 2010, with 1.

Clearances by year, as a table
510(k) clearance decisions for Cardiac Pacemakers, Inc., by decision year
YearClearances
19779
19786
19794
198014
19815
19829
19837
19843
19851
19866
19871
19882
19892
19901
19912
19921
19941
20081
20101
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K093969ACUITY BREAK-AWAY GUIDE CATHETERDQYSubstantially Equivalent
K080154ACUITY UNIVERSAL CUTTERDQYSubstantially Equivalent
K934727REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELERDWSSubstantially Equivalent
K920601ASTRA T2, ASTRA T4, ASTRA T6DXYSubstantially Equivalent
K912379PDT CARRYALL TRANSMITTER, VARIOUS MODELSDXHSubstantially Equivalent
K905674LEAD STYLETDRBSubstantially Equivalent
K900498MODIFIED BETATRON IV INSULIN INFUSION SYSTEMLZGSubstantially Equivalent
K894738MODEL 6888 LEAD TUNNELERDWSSubstantially Equivalent
K890785ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGEDXYSubstantially Equivalent
K875147TORQUE HEX WRENCHDTFSubstantially Equivalent
K872774BETATRON IV SYSTEMFRNSubstantially Equivalent
K865013ASTRA T2, T4 AND T6DXYSubstantially Equivalent
K863046ULTRA SOFTWARE MODULE: MODEL 2016KRGSubstantially Equivalent
K863045PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580KRGSubstantially Equivalent
K863000ASTRA 2,3,4 AND 6: CHIP REVISIONSubstantially Equivalent
K860585ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATORDXYSubstantially Equivalent
K860584SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GENKRGSubstantially Equivalent
K855171TELEMETRY WAND MODELDXYSubstantially Equivalent
K852060INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123FRNSubstantially Equivalent
K842394ASTRA 2, ASTRA 3, 4 & 6DXYSubstantially Equivalent
K842364HANDHELD PACEMAKER PROGRAMMER & SOFTWARKRGSubstantially Equivalent
K843060SENTRADTDSubstantially Equivalent
K833306BETATRON I AMBULATORY INSULIN PUMPFRNSubstantially Equivalent
K831216COMMAND ULTRA IIDXYSubstantially Equivalent
K831161COMMAND ULTRA IDXYSubstantially Equivalent
K831259RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLEFRNSubstantially Equivalent
K831160LEAD ADAPTERS #'S 6016,6022,6017 ETCDTDSubstantially Equivalent
K830382COMMAND ULTRA IIDXYSubstantially Equivalent
K822857CPI PRINTERKAGSubstantially Equivalent
K823204BETATRON IIFRNSubstantially Equivalent
K822776TEFLON CANNULAFOZSubstantially Equivalent
K822775INFUS. SETS-9120-50 CM & 9121-100 CM,EXTFPASubstantially Equivalent
K8227749110 SYRINGEFMFSubstantially Equivalent
K822309COMMAND NPDXYSubstantially Equivalent
K820231COMMAND ULTRA IDXYSubstantially Equivalent
K820230PACEMAKER PROGRAMMER 2030KRGSubstantially Equivalent
K820073OPEN LOOP AMBULATORY INSULIN INFUSIONFRNSubstantially Equivalent
K813534COMMAND P5DXYSubstantially Equivalent
K812917PORTABLE LIDOCAINE INFUSION PUMPFRNSubstantially Equivalent
K811402COMMAND P5(BIPOLAR PULSE GENERATOR)DXYSubstantially Equivalent
K811401COMMAND P5(UNIPOLAR PULSE GENERATOR)Substantially Equivalent
K811217PACEMAKER PROGRAMMER #2010KRGSubstantially Equivalent
K811774OPEN LOOP AMBULATORY INFUSION DEVICEFRNSubstantially Equivalent
K803035MICROTHIN-PII BIPOLAR PULSE GEN. #0621DXYSubstantially Equivalent
K803034MICROTHIN-PII BIPOLAR PULSE GEN. #0623DXYSubstantially Equivalent
K802353MICRO THIN-PII, #0523DXYSubstantially Equivalent
K802352MICRO THIN-DII, #0521DXYSubstantially Equivalent
K802058MAPPING PROBE MODEL #6540DRFSubstantially Equivalent
K802410MICROTHIN-PI BIPOLAR PULSE GENERATORDXYSubstantially Equivalent
K802409MICROTHIN-DI BIPOLAR PULSE GENERATORDXYSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain