MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)— 510(k) K961917
Substantially EquivalentMedtronics Interventional Vascular
FDA 510(k) clearance K961917 for MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX), Substantially Equivalent on 1996-11-20. Applicant: Medtronics Interventional Vascular. Device class: 2.
Clearance details
- Applicant
- Medtronics Interventional Vascular
- Product code
- Code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code DQX
view allMore clearances from Medtronics Interventional Vascular
view all- K990707 — MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS
- K980973 — MEDTRONIC ANGIOGRAPHIC CATHETER
- K982883 — MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER
- K981198 — MEDTRONIC ZUMA GUIDING CATHETER
- K972944 — MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT
Adverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
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.