510(k) K163231 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Chameleon PTA Balloon Catheter
| Applicant | Av Medical Technologies, Ltd., Tel-Aviv, IL |
| Decision | Substantially Equivalent, Jan 17, 2017 |
| Received | Nov 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163231
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2024 | Covidien LP 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 Open, Classified |
LIT | None listed |
| Feb 3, 2022 | Covidien Llc 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 Open, Classified |
LIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.