Rotarex Atherectomy System— 510(k) K242757
Substantially EquivalentBard Peripheral Vascular, Inc.
FDA 510(k) clearance K242757 for Rotarex Atherectomy System, Substantially Equivalent on 2025-01-30. Applicant: Bard Peripheral Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Bard Peripheral Vascular, Inc.
- Product code
- Code MCW
- Device class
- Class 2
- Regulation
- 21 CFR 870.4875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tempe, AZ, US
Recent devices under product code MCW
view all- K260244 — Auryon Atherectomy System
- K250723 — FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
- K250385 — Turbo-Elite Laser Atherectomy Catheter
- K242947 — FreedomFlow Orbital Circumferential Atherectomy System
- K241553 — Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
More clearances from Bard Peripheral Vascular, Inc.
view allAdverse events under product code MCW
product code MCW- Death
- 38
- Injury
- 1,386
- Malfunction
- 2,676
- Other
- 2
- Total
- 4,102
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 K242757
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 K242757.
Data sourced from openFDA. This site is unofficial and independent of the FDA.