Company ยท US
Cardiac Pacemakers, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2010. Name variants (Inc, Corp, punctuation) are merged.
76510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | 37 |
| FRN | Pump, Infusion | 8 |
| KRG | Programmer, Pacemaker | 7 |
| DTD | Pacemaker Lead Adaptor | 5 |
| DQY | Catheter, Percutaneous | 2 |
| DRB | Stylet, Catheter | 2 |
| DWS | Instruments, Surgical, Cardiovascular | 2 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 2 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 1 |
| DRR | Amplifier And Signal Conditioner, Biopotential | 1 |
| DTA | Tester, Pacemaker Electrode Function | 1 |
| DTF | Tools, Pacemaker Service | 1 |
| FMF | Syringe, Piston | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| KAG | Holder, Speculum, Ent | 1 |
| LZG | Pump, Infusion, Insulin | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 5, 2010 | K093969 | ACUITY BREAK-AWAY GUIDE CATHETER Cardiac Pacemakers, Inc. | DQY |
| Mar 20, 2008 | K080154 | ACUITY UNIVERSAL CUTTER Cardiac Pacemakers, Inc. | DQY |
| Jan 10, 1994 | K934727 | REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER Cardiac Pacemakers, Inc. | DWS |
| Oct 28, 1992 | K920601 | ASTRA T2, ASTRA T4, ASTRA T6 Cardiac Pacemakers, Inc. | DXY |
| Jun 17, 1991 | K912379 | PDT CARRYALL TRANSMITTER, VARIOUS MODELS Cardiac Pacemakers, Inc. | DXH |
| Jan 30, 1991 | K905674 | LEAD STYLET Cardiac Pacemakers, Inc. | DRB |
| Feb 23, 1990 | K900498 | MODIFIED BETATRON IV INSULIN INFUSION SYSTEM Cardiac Pacemakers, Inc. | LZG |
| Sep 13, 1989 | K894738 | MODEL 6888 LEAD TUNNELER Cardiac Pacemakers, Inc. | DWS |
| Mar 10, 1989 | K890785 | ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE Cardiac Pacemakers, Inc. | DXY |
| Jan 27, 1988 | K875147 | TORQUE HEX WRENCH Cardiac Pacemakers, Inc. | DTF |
| Jan 5, 1988 | K872774 | BETATRON IV SYSTEM Cardiac Pacemakers, Inc. | FRN |
| Feb 19, 1987 | K865013 | ASTRA T2, T4 AND T6 Cardiac Pacemakers, Inc. | DXY |
| Dec 5, 1986 | K863046 | ULTRA SOFTWARE MODULE: MODEL 2016 Cardiac Pacemakers, Inc. | KRG |
| Sep 29, 1986 | K863045 | PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580 Cardiac Pacemakers, Inc. | KRG |
| Aug 19, 1986 | K863000 | ASTRA 2,3,4 AND 6: CHIP REVISION Cardiac Pacemakers, Inc. | |
| Jul 16, 1986 | K860585 | ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR Cardiac Pacemakers, Inc. | DXY |
| Jun 6, 1986 | K860584 | SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN Cardiac Pacemakers, Inc. | KRG |
| Jan 22, 1986 | K855171 | TELEMETRY WAND MODEL Cardiac Pacemakers, Inc. | DXY |
| Jun 7, 1985 | K852060 | INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123 Cardiac Pacemakers, Inc. | FRN |
| Oct 17, 1984 | K842394 | ASTRA 2, ASTRA 3, 4 & 6 Cardiac Pacemakers, Inc. | DXY |
| Sep 24, 1984 | K842364 | HANDHELD PACEMAKER PROGRAMMER & SOFTWAR Cardiac Pacemakers, Inc. | KRG |
| Sep 20, 1984 | K843060 | SENTRA Cardiac Pacemakers, Inc. | DTD |
| Nov 28, 1983 | K833306 | BETATRON I AMBULATORY INSULIN PUMP Cardiac Pacemakers, Inc. | FRN |
| Jul 12, 1983 | K831216 | COMMAND ULTRA II Cardiac Pacemakers, Inc. | DXY |
| Jun 15, 1983 | K831161 | COMMAND ULTRA I Cardiac Pacemakers, Inc. | DXY |
| May 9, 1983 | K831259 | RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE Cardiac Pacemakers, Inc. | FRN |
| May 9, 1983 | K831160 | LEAD ADAPTERS #'S 6016,6022,6017 ETC Cardiac Pacemakers, Inc. | DTD |
| Mar 17, 1983 | K830382 | COMMAND ULTRA II Cardiac Pacemakers, Inc. | DXY |
| Jan 8, 1983 | K822857 | CPI PRINTER Cardiac Pacemakers, Inc. | KAG |
| Nov 30, 1982 | K823204 | BETATRON II Cardiac Pacemakers, Inc. | FRN |
| Nov 3, 1982 | K822776 | TEFLON CANNULA Cardiac Pacemakers, Inc. | FOZ |
| Nov 3, 1982 | K822775 | INFUS. SETS-9120-50 CM & 9121-100 CM,EXT Cardiac Pacemakers, Inc. | FPA |
| Nov 3, 1982 | K822774 | 9110 SYRINGE Cardiac Pacemakers, Inc. | FMF |
| Oct 4, 1982 | K822309 | COMMAND NP Cardiac Pacemakers, Inc. | DXY |
| Mar 15, 1982 | K820231 | COMMAND ULTRA I Cardiac Pacemakers, Inc. | DXY |
| Mar 15, 1982 | K820230 | PACEMAKER PROGRAMMER 2030 Cardiac Pacemakers, Inc. | KRG |
| Jan 25, 1982 | K820073 | OPEN LOOP AMBULATORY INSULIN INFUSION Cardiac Pacemakers, Inc. | FRN |
| Jan 22, 1982 | K813534 | COMMAND P5 Cardiac Pacemakers, Inc. | DXY |
| Nov 6, 1981 | K812917 | PORTABLE LIDOCAINE INFUSION PUMP Cardiac Pacemakers, Inc. | FRN |
| Jul 27, 1981 | K811402 | COMMAND P5(BIPOLAR PULSE GENERATOR) Cardiac Pacemakers, Inc. | DXY |
| Jul 27, 1981 | K811401 | COMMAND P5(UNIPOLAR PULSE GENERATOR) Cardiac Pacemakers, Inc. | |
| Jul 20, 1981 | K811217 | PACEMAKER PROGRAMMER #2010 Cardiac Pacemakers, Inc. | KRG |
| Jul 10, 1981 | K811774 | OPEN LOOP AMBULATORY INFUSION DEVICE Cardiac Pacemakers, Inc. | FRN |
| Dec 22, 1980 | K803035 | MICROTHIN-PII BIPOLAR PULSE GEN. #0621 Cardiac Pacemakers, Inc. | DXY |
| Dec 22, 1980 | K803034 | MICROTHIN-PII BIPOLAR PULSE GEN. #0623 Cardiac Pacemakers, Inc. | DXY |
| Dec 22, 1980 | K802353 | MICRO THIN-PII, #0523 Cardiac Pacemakers, Inc. | DXY |
| Dec 22, 1980 | K802352 | MICRO THIN-DII, #0521 Cardiac Pacemakers, Inc. | DXY |
| Nov 19, 1980 | K802058 | MAPPING PROBE MODEL #6540 Cardiac Pacemakers, Inc. | DRF |
| Oct 31, 1980 | K802410 | MICROTHIN-PI BIPOLAR PULSE GENERATOR Cardiac Pacemakers, Inc. | DXY |
| Oct 31, 1980 | K802409 | MICROTHIN-DI BIPOLAR PULSE GENERATOR Cardiac Pacemakers, Inc. | DXY |
Newest 50 of 76.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||