BASIXCONPAK ANALOG INFLATION SYRINGE— 510(k) K122321
Substantially EquivalentMerit Medical Ireland, Ltd.
FDA 510(k) clearance K122321 for BASIXCONPAK ANALOG INFLATION SYRINGE, Substantially Equivalent on 2012-12-19. Applicant: Merit Medical Ireland, Ltd.. Device class: 2.
Clearance details
- Applicant
- Merit Medical Ireland, Ltd.
- 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
- South Jordan, UT, 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 Merit Medical Ireland, Ltd.
view allAdverse 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 →
Recalls naming K122321
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 K122321.
Data sourced from openFDA. This site is unofficial and independent of the FDA.