MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD— 510(k) K933731
Substantially EquivalentMedtronic Vascular
FDA 510(k) clearance K933731 for MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD, Substantially Equivalent on 1994-03-21. Applicant: Medtronic Vascular. Device class: 3.
Clearance details
- Applicant
- Medtronic Vascular
- Product code
- Code DTB
- Device class
- Class 3
- Regulation
- 21 CFR 870.3680
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code DTB
view allMore clearances from Medtronic Vascular
view all- K232570 — Steerant Super Stiff Guidewire
- K232190 — 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
- 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 DTB
product code DTB- Death
- 1,491
- Injury
- 67,311
- Malfunction
- 79,368
- Other
- 10
- Total
- 148,180
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.