Axium Detachable Coil; Axium Prime Detachable Coil— 510(k) K203432
Substantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
FDA 510(k) clearance K203432 for Axium Detachable Coil; Axium Prime Detachable Coil, Substantially Equivalent on 2021-07-07. 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 HCG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code HCG
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
- K203358 — Solitaire X Revascularization Device
Adverse events under product code HCG
product code HCG- Death
- 50
- Injury
- 801
- Malfunction
- 5,625
- Total
- 6,476
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 K203432
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 K203432.
Data sourced from openFDA. This site is unofficial and independent of the FDA.