BIPOLAR ENDOCARDIAL LEAD 406L— 510(k) K841227
Substantially EquivalentSiemens Elema AB
FDA 510(k) clearance K841227 for BIPOLAR ENDOCARDIAL LEAD 406L, Substantially Equivalent on 1984-11-27. Applicant: Siemens Elema AB. Device class: 2.
Clearance details
- Applicant
- Siemens Elema AB
- Product code
- Code DTD
- Device class
- Class 2
- Regulation
- 21 CFR 870.3620
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code DTD
view all- 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
More clearances from Siemens Elema AB
view allData sourced from openFDA. This site is unofficial and independent of the FDA.