MEDTRONIC MODEL 4558M— 510(k) K940703
UnknownMedtronic Vascular
FDA 510(k) clearance K940703 for MEDTRONIC MODEL 4558M, Unknown on 1994-11-04. 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
- Unknown
- 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 →
Recalls naming K940703
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K940703.
Data sourced from openFDA. This site is unofficial and independent of the FDA.