LEMAITRE 8F OCCLUSION CATHETER— 510(k) K132022
Substantially EquivalentLeMaitre Vascular, Inc.
FDA 510(k) clearance K132022 for LEMAITRE 8F OCCLUSION CATHETER, Substantially Equivalent on 2013-11-06. Applicant: LeMaitre Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- LeMaitre Vascular, Inc.
- Product code
- Code MJN
- Device class
- Class 2
- Regulation
- 21 CFR 870.4450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code MJN
view allMore clearances from LeMaitre Vascular, Inc.
view allAdverse events under product code MJN
product code MJN- Death
- 31
- Injury
- 240
- Malfunction
- 827
- Total
- 1,098
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 K132022
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 K132022.
Data sourced from openFDA. This site is unofficial and independent of the FDA.