MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT— 510(k) K960983
Substantially EquivalentMedtronics Interventional Vascular
FDA 510(k) clearance K960983 for MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT, Substantially Equivalent on 1996-05-30. Applicant: Medtronics Interventional Vascular. Device class: 2.
Clearance details
- Applicant
- Medtronics Interventional Vascular
- Product code
- Code MAV
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danvers, MA, US
Recent devices under product code MAV
view all- K260035 — Digital Indeflator INFLANTE
- K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200) +3 more
- K162272 — Fluent inflation device
- K153038 — Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
- K153672 — basixTOUCH40 Inflation Syringe
More 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 MAV
product code MAV- Malfunction
- 1,433
- Total
- 1,433
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.