VISIONS PV .035 DITITAL IVUS CATHETER— 510(k) K121273
Substantially EquivalentVolcano Corporation
FDA 510(k) clearance K121273 for VISIONS PV .035 DITITAL IVUS CATHETER, Substantially Equivalent on 2012-09-10. Applicant: Volcano Corporation. Device class: 2.
Clearance details
- Applicant
- Volcano Corporation
- Product code
- Code OBJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- San Diego, CA, US
Recent devices under product code OBJ
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- K190626 — SyncVision System
Adverse events under product code OBJ
product code OBJ- Death
- 38
- Injury
- 634
- Malfunction
- 3,453
- Total
- 4,125
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 K121273
K-number listed on FDA's recall record- Z-1301-2022 — Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
- Z-0726-2019 — Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices.
- Z-1844-2015 — Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121273.
Data sourced from openFDA. This site is unofficial and independent of the FDA.