ECHELON MICRO CATHETER, MODEL 105-5092-150— 510(k) K030688
Substantially EquivalentMicro Therapeutics, Inc.
FDA 510(k) clearance K030688 for ECHELON MICRO CATHETER, MODEL 105-5092-150, Substantially Equivalent on 2003-03-28. Applicant: Micro Therapeutics, Inc.. Device class: 2.
Clearance details
- Applicant
- Micro Therapeutics, Inc.
- Product code
- Code KRA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
Recent devices under product code KRA
view allMore clearances from Micro Therapeutics, Inc.
view allAdverse events under product code KRA
product code KRA- Death
- 234
- Injury
- 1,029
- Malfunction
- 3,012
- Other
- 2
- Total
- 4,277
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 K030688
K-number listed on FDA's recall record- Z-1556-2022 — Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
- Z-1557-2022 — Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030688.
Data sourced from openFDA. This site is unofficial and independent of the FDA.