MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR— 510(k) K910237
Substantially EquivalentMedtronic Vascular
FDA 510(k) clearance K910237 for MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR, Substantially Equivalent on 1991-02-25. Applicant: Medtronic Vascular. Device class: 2.
Clearance details
- Applicant
- Medtronic Vascular
- 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
- Minneapolis, MN, US
Recent devices under product code DTE
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- K230156 — 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
- K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200) +3 more
- K192296 — Medtronic 6F Taiga Guiding Catheter
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.