MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER— 510(k) K904409
Substantially EquivalentMedtronic Vascular
FDA 510(k) clearance K904409 for MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER, Substantially Equivalent on 1991-01-30. Applicant: Medtronic Vascular. Device class: 2.
Clearance details
- Applicant
- Medtronic Vascular
- Product code
- Code GZF
- Device class
- Class 2
- Regulation
- 21 CFR 882.5870
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code GZF
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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 GZF
product code GZF- Death
- 10
- Injury
- 2,410
- Other
- 1
- Total
- 2,421
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.