Chameleon
PTA Balloon Catheter with Injection Port
5manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Vascupatent Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Mozarc Medical US LLC, United States |
|---|---|
| FDA product code | KRA |
| Device type | Catheter, Continuous Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1210 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2021-11-22 |
| Record revised | 2025-12-15 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment atmospheric pressure up to 1419 KiloPascal; Special storage condition: Keep dry |
| Sizes | Length 40 mm; catheter gauge 5.9 Fr; outer diameter 5 to 12 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CH07-40-75US | Length 40 mm | In distribution |
| CH12-40-75US | Catheter Gauge 5.9 Fr | In distribution |
| CH08-40-75US | Outer Diameter 8 mm | In distribution |
| CH05-40-75US | Outer Diameter 5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fountain® | Merit Medical Systems, Inc. | 154 |
| PulseSpray | AngioDynamics, Inc. | 149 |
| Merit Maestro® | Merit Medical Systems, Inc. | 143 |
| Phenom™ Catheter | Cathera, Inc. | 103 |
| UniFuse | AngioDynamics, Inc. | 84 |
| CXI | Cook Incorporated | 48 |
| Uni-Fuse+ | AngioDynamics, Inc. | 32 |
| Prowler | Medos International Sàrl | 27 |
| Truwave, Vamp | Edwards Lifesciences Technology Sarl | 26 |
| ICU Medical | ICU Medical, Inc | 21 |
| Cantata | Cook Incorporated | 20 |
| Truwave, Vamp Plus | Edwards Lifesciences Technology Sarl | 19 |
Showing 12 of 149. All products under Catheter, Continuous Flush
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | UDI-DI | 2024-09-19 | Class II | Under Investigation by firm | Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing. | 16,336 units |
| Covidien | UDI-DI | 2021-12-17 | Class II | Under Investigation by firm | The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while re | 1,994 devices |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.