FRIMAP ADAPTER CONNECTOR (MAC)— 510(k) K142182
Substantially EquivalentTopera, Inc.
FDA 510(k) clearance K142182 for FRIMAP ADAPTER CONNECTOR (MAC), Substantially Equivalent on 2014-09-09. Applicant: Topera, Inc.. Device class: 2.
Clearance details
- Applicant
- Topera, Inc.
- Product code
- Code MTD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- St.Louis, MO, US
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More clearances from Topera, Inc.
view allAdverse events under product code MTD
product code MTD- Death
- 22
- Injury
- 376
- Malfunction
- 986
- Total
- 1,384
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 K142182
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 K142182.
Data sourced from openFDA. This site is unofficial and independent of the FDA.