SYNC-RX SYSTEM— 510(k) K132558
Substantially EquivalentVolcano Corporation
FDA 510(k) clearance K132558 for SYNC-RX SYSTEM, Substantially Equivalent on 2013-12-12. Applicant: Volcano Corporation. Device class: 2.
Clearance details
- Applicant
- Volcano Corporation
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Billerica, MA, US
Recent devices under product code OWB
view allMore clearances from Volcano Corporation
view all- K210235 — Verrata PLUS Pressure Guide Wire
- K203719 — IntraSight Mobile
- K202543 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
- K192886 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
- K190626 — SyncVision System
Adverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
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 K132558
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 K132558.
Data sourced from openFDA. This site is unofficial and independent of the FDA.