MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE— 510(k) K141516
Substantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
FDA 510(k) clearance K141516 for MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE, Substantially Equivalent on 2015-02-05. Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Device class: 2.
Clearance details
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Product code
- Code NRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code NRY
view allMore clearances from Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
view all- K241388 — Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter
- K243418 — Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing
- K243080 — Riptide Aspiration System
- K211990 — Rist 071 Radial Access Guide Catheter
- K203432 — Axium Detachable Coil; Axium Prime Detachable Coil
Adverse events under product code NRY
product code NRY- Death
- 411
- Injury
- 1,712
- Malfunction
- 1,855
- Total
- 3,978
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 K141516
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 K141516.
Data sourced from openFDA. This site is unofficial and independent of the FDA.