Product code DTD— Cardiovascular
ADAPTER KIT
- Classification name
- Pacemaker Lead Adaptor
- Device class
- Class 2
- Regulation
- 21 CFR 870.3620
- Advisory panel
- Cardiovascular
- Total cleared
- 103
- First cleared
- Most recent
Market context for product code DTD
FDA has cleared devices under product code DTD between 1977 and 2015, filed by 23 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2015
- 2013
- 2004
- 2003
- 2001
- 2000
- 1998
- 1997
- 1995
- 1994
- 1992
- 1991
- 1990
- 1989
- 1987
Top applicants under product code DTD
Recent clearances under product code DTD
1–100 of 103- K143463 — IS4/DF4 Port Plug
- K132008 — 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP
- K041574 — CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020
- K031164 — PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
- K024156 — PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR
- K010787 — PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
- K003454 — A1-CS-SB Y-ADAPTER, MODEL 124 871
- K000210 — MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
- K982220 — MODEL 2872 BIPOLAR LEAD ADAPTOR KIT
- K970388 — A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE
- K971930 — BK-N SEALING CAP
- K970204 — BK-A; BK-B; BK-IS SEALING CAP
- K950140 — IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069
- K934899 — BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM
- K925168 — MISCELLANEOUS PACING LEAD
- K921318 — ADAPTING SLEEVE KIT MODEL 4023
- K915724 — MODEL 6984M LEAD EXTENDER KIT
- K912773 — UNIPOLAR UPSIZING ADAPTOR
- K911142 — LEAD TERMINAL PIN CAPS, VARIOUS MODELS
- K911302 — MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT
- K911827 — MODEL 5866-9M & MODEL 6981M
- K910630 — MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT
- K911048 — MODEL 5857-3M LEAD END CAP KIT
- K910112 — BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR
- K904575 — MODEL 5866-37M LEAD ADAPTOR KIT
- K902889 — A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.
- K900512 — SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS
- K900627 — MODEL 5866-34 LEAD ADAPTOR KIT
- K896438 — UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER
- K890895 — IMPLANTABLE ADAPTOR 033-380
- K900605 — 3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100
- K895971 — TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING
- K894976 — ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP.
- K894718 — ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33
- K870562 — DAIG PACEMAKER LEAD ADAPTOR
- K862656 — PACEMAKER LEAD ADAPTER
- K860832 — MODEL 366-08 ADAPTAID CONNECTOR ADAPTER
- K854997 — IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY
- K844814 — BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD
- K850968 — MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN
- K851897 — CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD
- K852356 — MEDTRONIC MODEL 5561
- K852253 — 329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR
- K851457 — MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD
- K851458 — MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD
- K851890 — MEDTRONIC 5064
- K851665 — PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE
- K851145 — PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD
- K850652 — PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD
- K844974 — MEDTRONIC 5061 ENDOCARDIAL PACING LEAD
- K850576 — PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR
- K844857 — PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD
- K841450 — BIOTRONIK DNP UNIPOLAR
- K841451 — BIOTRONIK DY-UNIPOLAR
- K844687 — MEDTRONIC MODEL 6912
- K842065 — EPICARDIAL, UNIPOLAR LEAD 4951
- K842145 — TRANSVENOUS TINED VENTRICULAR LEAD
- K843703 — PERMATHANE 865 & 867 UNIPOLAR POLYURETH
- K841227 — BIPOLAR ENDOCARDIAL LEAD 406L
- K843060 — SENTRA
- K841739 — MODEL 866 PERMATHANE BIPOLAR, COAXIAL
- K841885 — FASTPASS IMPLANTABLE ENDOCARDIAL PAC
- K840025 — IMPLANTABLE ELECTRODE BIPOLAR ADAPT
- K840026 — IMPLANTABLE ELECTRODE UNIPOLAR ADAPT
- K831160 — LEAD ADAPTERS #'S 6016,6022,6017 ETC
- K822704 — MODEL 366-07 ADAPT AID LEAD ADAPTER
- K821547 — PACEMAKER UNIPOLAR ADAPTER
- K821548 — PACEMAKER CONNECTOR PLUG
- K821549 — PACEMAKER 445 ADAPTER
- K820935 — MODEL 5866-26 LEAD ADAPTER KIT
- K813151 — VITATRON INSERT
- K813152 — ELECTRODE TERMINAL CAP
- K813154 — ADAPTING SLEEVE
- K812756 — ADAPTAID #365-38
- K812812 — INTERMEDICS ADAPTAID STEP-DOWN ADAPTER
- K811920 — ADAPTAID LEAD ADAPTER, #365-17
- K811938 — ADAPTAID LEAD ADAPTER #365-25
- K811349 — MODEL 5866-24 LEAD ADAPTOR KIT
- K810551 — PACEMAKER LEAD ADAPTER
- K810245 — IMPLANTABLE PACEMAKER LEAD ADAPTER
- K802407 — PACEMAKER LEAD ADAPTOR MODEL 431
- K802077 — UNIPOLAR TO BIPOLAR PULSE GEN. ADAPTER
- K801039 — ADAPTAID HELICAL COIL ADAPTER 365-14
- K801038 — ADAPTAID ELEMA LEAD ADAPTER KIT 365-17
- K801040 — GE LEAD ADAPTER, MODEL 345-01
- K800353 — ADAPTER KIT
- K790218 — BIPOLAR LEAD ADAPTOR, MODEL BA-415
- K790436 — IMPLANTABLE HEART LEAD TERMINAL ADAPTER
- K790468 — IMPLANTABLE HEART LEAD EXTENDER
- K781822 — ELECTRODE, MODEL 030-324
- K781823 — ELECTRODE, MODEL 030-326
- K781824 — ELECTRODE, MODEL 030-324/4 GUAGE
- K782097 — ELECTRODE LEAD MODEL 030-198
- K781864 — ADAPTER KIT
- K781622 — PACING LEAD ADAPTER MODEL ACS 16
- K781626 — PACING LEAD ADAPTER, ACV 14, ACV 23
- K781627 — PACING LEAD ADAPTER MODEL ADB 21
- K772058 — LEAD ADAPTOR KIT MODEL 5866-21
- K771641 — UNIVERSAL LEAD ADAPTER, UA-414
- K771642 — ADAPTER A-413
Data sourced from openFDA. This site is unofficial and independent of the FDA.