PULSE GENERATOR, MODEL 240, EXTERNAL— 510(k) K781327
Substantially EquivalentIntermedics, Inc.
FDA 510(k) clearance K781327 for PULSE GENERATOR, MODEL 240, EXTERNAL, Substantially Equivalent on 1978-12-11. Applicant: Intermedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Intermedics, Inc.
- Product code
- Code DTE
- Device class
- Class 2
- Regulation
- 21 CFR 870.3600
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code DTE
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- K955550 — CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
- K960281 — IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY
Adverse events under product code DTE
product code DTE- Death
- 18
- Injury
- 247
- Malfunction
- 4,603
- Total
- 4,868
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.