Chameleon PTA Balloon Catheter— 510(k) K163231
Substantially EquivalentAv Medical Technologies, Ltd.
FDA 510(k) clearance K163231 for Chameleon PTA Balloon Catheter, Substantially Equivalent on 2017-01-17. Applicant: Av Medical Technologies, Ltd.. Device class: 2.
Clearance details
- Applicant
- Av Medical Technologies, Ltd.
- Product code
- Code LIT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tel-Aviv, IL
Recent devices under product code LIT
view allMore clearances from Av Medical Technologies, Ltd.
view allAdverse events under product code LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
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 K163231
K-number listed on FDA's recall record- Z-0257-2025 — Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US), 12mm x 40mm x 75cm (CFN CH12-40-75US)
- Z-0557-2022 — Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163231.
Data sourced from openFDA. This site is unofficial and independent of the FDA.